Man with curly black hair and beard wears a striped shirt under his white lab coat, safety googles, and blue latex gloves while examining a test tube of transparent green liquid.

Inside Seres

Seres is defined by its extraordinary people, and their passion is what drives us on our mission to help patients.

Make your mark on the medical breakthroughs of tomorrow

At Seres, we’re leading the microbiome revolution — and our most revolutionary asset is our team. We’re courageous and deeply collaborative, and above all we’re passionate about the commitment we’ve made to blaze a new trail for the benefit of patients.

We are proud of our achievements thus far — including moving multiple novel therapeutics to the clinic for patients — achievements made possible by our amazing teams across the company.

Just as combinations of bacteria perform challenging biological tasks together, integration of our diverse expertise and insights is allowing us to drive the microbiome revolution and change the face of medicine for patients in need.

Join the revolution. Explore our open jobs below.

Meet our
team

One of the most exciting projects I’ve been involved in is putting together our state-of-the-art gnotobiotic program. This technology is really unique to Seres, and I was very proud to have been part of it. Outside of work I enjoy travel, riding motorcycles, and I am an avid bar trivia connoisseur.

Keith H.

Manager, In Vivo Pharmacology

A highlight of working at Seres is the ability to collaborate with scientists of many different backgrounds, which has given me the opportunity to learn new skill sets and think of problems from different angles. When I'm not at Seres I sing co-lead for a six-part rock band with friends from the North Shore. We currently play mostly covers, and we plan to book some shows at local venues while we work on more of our original material.

Shelby E.

Senior Associate in Analytical Development

It was great to be part of the team involved with our cluster computing project. The project took a lot of hard work but has become the backbone of our computational pipeline at Seres. One day I would like to create an AI/deep learning framework that can accelerate drug design by continuously crunching data and generating hypotheses without human intervention. I'd obviously make sure it didn't become sentient and evil... more Wall-E, less HAL.

Varun M.

Senior Scientist, Computational Biology

I always look forward to R&D's Data and Donuts presentations, which is a casual environment to present research-in-progress and receive feedback and ideas from a wider audience. Outside of science, I have taught group exercise for almost ten years. It started as a fun way to get physical activity and exert energy in college, but now is a great way to end the workday and maintain a healthy life-work balance.

Mahmoud S.

Scientist II, Microbiology and Functional Screening

I love to interact with the people at Seres, from old coworkers up to new hires – that is the best part of my day. My passion outside of work is drawing, painting and custom action figures. I want to put together several paintings for an exhibition someday.

Luis M.

Facilities Manager

Get to
know us

There’s so much more of Seres to discover. Find our team on LinkedIn and connect with us to start a conversation.

See who you know at Seres

Open
positions

Associate Director / Director of Contamination Control & Investigator

Seres Therapeutics is a dynamic biotechnology company in Cambridge MA pioneering innovative Ecobiotic® microbiome therapeutics.  Seres has promising late clinical stage programs for treatment of recurrent Clostridium difficile infection and Ulcerative Colitis and is well-positioned to become the first company to commercialize a new therapeutic modality comprising ecologies of commensal bacteria.  Seres plans to enter the clinic with multiple new product candidates in a range of therapeutic areas including immuno-oncology and inflammation to build upon its field-leading portfolio of intellectual property and know-how.
We are seeking a highly motivated head of contamination control for Seres manufacturing pipeline products. The individual will be responsible for development, improvement, implementation and maintenance of the contamination control programs including bioburden, virus, and particles to align with regulatory requirements and commitments for clinical/commercial products.  The individual will work closely within the Quality and CMC/manufacturing organizations both internal and externally to ensure robust programs.  The individual will have strong facilitation skills to investigate complex issues with cross-functional stakeholders. 

Key Responsibilities:

  • Develop contamination control programs using a risk-based approach for bioburden, virus, and particles meeting regulatory requirements and commitments for clinical/commercial products.
  • Author and/or revise internal procedures and develop and implement programs related to contamination control. 
  • Develop and provide oversight of gowning, cleaning, and personnel flow in clean room areas for the site.
  • Lead investigations and/or participate in cross-functional investigations as a subject matter expert to ensure compliance with established contamination control programs
  • Perform periodic review and analysis of data for any trending and trend limits for bioburden, virus, or particles.
  • Facilitate root cause investigations to resolve any contamination control issues. 
  • Oversee program at the Cambridge manufacturing site and at external contract manufacturing organizations. 
  • Some travel required to external CMOs (10%) 


Qualifications:

  • BA/BS or MS degree in Microbiology, Virology, Biology, Chemistry or other related field with 10+ years of GMP experience within quality control 
  • Strong project management skills
  • Risk management (FMEA, Is/Is not)
  • Demonstrate knowledge of USP, EP, JP monographs 
  • Demonstrate knowledge of cGMP/ICH/FDA/EU regulations
  • Demonstrate a strong initiative and scientific leadership
  • Collaborative team player who fosters open communication and builds relationships with stakeholders 
  • Self-directed individual who can work with limited direction in a fast-paced environment
  • Strong analytical, organization, and communication skills with a positive attitude.
  • Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines
  • Experience with developing and implementation of contamination control programs for microbiome products.
  • Experience with preparing regulatory documentation 
Apply for the Associate Director / Director of Contamination Control & Investigator position

Associate Director / Director, Quality Control

Seres Therapeutics is a dynamic biotechnology company in Cambridge MA pioneering innovative Ecobiotic® microbiome therapeutics.  Seres has promising late clinical stage programs for treatment of recurrent Clostridium difficile infection and Ulcerative Colitis and is well-positioned to become the first company to commercialize a new therapeutic modality comprising ecologies of commensal bacteria.  Seres plans to enter the clinic with multiple new product candidates in a range of therapeutic areas including immuno-oncology and inflammation to build upon its field-leading portfolio of intellectual property and know-how.  Seres is preparing for pre-approval inspection and commercial launch.


We are seeking a highly motivated head of the Quality Control laboratories for Seres manufacturing pipeline products. The individual will be responsible for improvement, development, implementation and maintenance for all of the QC related testing activities such as Environmental, Water, and Drug Product release testing activities for Seres sites and products. The position leads and supports the development, implementation, and maintenance of Quality Control (Microbiology) systems and activities for Seres.

Key Responsibilities:

  • Execute management duties in accordance with company policies and practices.
  • Direct staff to ensure timely and accurate execution of projects in full compliance with safety, budget, cGMP and other regulatory standards as required.
  • Ensure the necessary daily, weekly, monthly, and quarterly department meetings are held to drive compliance and adherence to plan.
  • Recommend improvements to the active facility based on data and risk assessments as part of a cross functional team with Quality, Facilities, Engineering, and manufacturing.
  • Oversee sampling and testing of clean rooms and purified water systems in the manufacturing environment including training, review, reporting, and trending of data.
  • Ensure timely analysis of samples and release of products while adhering to procedures and regulations.
  • Assume ownership of assigned quality documentation, such as exceptions, change controls, Environmental Excursions, and CAPAs, ensuring that documentation is initiated and closed on time, required actions are thorough and meet procedural requirements as well as customer needs.
  • Author, revise, and approve SOPs to improve efficiency and regulatory compliance and author and/or facilitate process risk assessments based on best practices and process details.
  • Ensure alignment of Environmental Monitoring and Water System policies and procedures.
  • Lead and direct continuous improvement efforts within the department by developing more efficient techniques, processes, and procedures, adapting new technologies, and enhancing capabilities as well as smart automation.
  • Hire, mentor, motivate and challenge to drive high performance and develop team members, and developing staff to solve complex problems.

 

  • Work cross-functionally to develop QC systems that meet the standards expected by US and global regulatory authorities in support of clinical stage products and prepare the laboratory for pre-approval inspection for commercial launch.
  • Oversee the microbiology test methods and release tests to meet the company’s quality standards and applicable regulations.
  • Review, trend and present QC data to senior management quarterly.
  • Review and approve QC laboratory SOPs, protocols and reports.
  • Oversee QC laboratory excursions, including; deviations, OOS, OOT and atypical investigations.
  • Participate in preparation of regulatory inspections and facility audits.

Qualifications:

  • BA/BS or MS degree in Microbiology, Biology, Chemistry, Biochemistry,  or other related field with 15+ years of cGMP experience within Quality Control 
  • Strong project management skills
  • Demonstrate knowledge of USP, EP, JP monographs 
  • Demonstrate knowledge of cGMP/ICH/FDA/EU regulations
  • Demonstrate a strong initiative and scientific leadership
  • Strong knowledge of cGMPS and Quality Systems
  • Strong background on data integrity
  • Knowledge of Laboratory Information Management Systems (LIMS)
  • Experience with aseptic technique and clean room qualification per ISO 14644.
  • Collaborative team player who fosters open communication and builds relationships with stakeholders 
  • Self-directed individual who can work with limited direction in a fast-paced environment
  • Strong analytical, organization, and communication skills with a positive attitude.
  • Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines
  • Experience with preparing regulatory documentation 
Apply for the Associate Director / Director, Quality Control position

Associate Director, Donation Operations  

Seres Therapeutics is well-positioned to become the first company to bring an approved microbiome drug to patients through our proprietary discovery and design platform.  We identify key alterations in the gut microbiome and design live bacterial ecologies to act as novel, groundbreaking therapeutics.

This high impact, leadership role will drive the infrastructure for a pioneering new donor sourced material program through operational partnership and excellence.  The ideal candidate will be an experienced operational and cross functional collaborator with an adaptable, all hands-on deck approach to accelerate this unique program from facilities launch through long term operational excellence. This leader will have high visibility and impact while leading the strategic evolution of a unique network of facilities and sustained management of this novel donor sourced material program.  This is a donor facing role and will set an example for a positive donor experience throughout the program.

Core Capabilities:

  • Manage and drive operational excellence for a donor sourced material program in line with regulatory and quality assurance requirements
  • Partner closely with the Head of Donor Recruitment, Head of Donor Medical Sciences and Head of Donor Analytical Sciences to develop and implement network-wide strategy in support of the Seres Therapeutics donor supply chain
  • Oversee scoping, launch, and long-term operational management of multiple satellite facilities across the US
  • Strategic forward planning to improve facility and program capacity and capabilities to meet high volume deliverables
  • Drive continual process and performance improvements for the program and staff

Responsibilities:

  • Responsible for the operational performance of the donor program
  • General facility management and maintenance
  • Author and revise controlled documents for process improvements
  • Manage budget, service contracts, space and capacity planning
  • Oversee and ensure high quality of work from facility employees
  • Manage staff across multiple remote facilities within the US

Qualifications / Skills:

  • Bachelor’s degree preferably in Science, Nursing, Engineering or related field, Master’s degree preferred
  • Minimum of 3-5 years of related experience in a clinical, blood donor or other relevant setting required
  • Prior management experience, preferably supervising a group of 10 or more employees required
  • Strong project management, customer service, and communication skills required
  • Proven track record of both strategy development and operational execution required
  • Experience with Operational Excellence / Lean / Continuous Improvement strongly preferred
  • Experience in a clinical, quality control and/or cGMP regulated environment strongly preferred
  • Experience with plasma or whole blood preferred

 

Apply for the Associate Director, Donation Operations   position

As part of the Quality Systems Shared Services Group, this role will act as a QS champion working with GxP functions (GCP, GMP) supporting operational activities responsible for Quality Supplier Management, Quality Risk Management, Internal Auditing and Inspection Readiness.  This role will also support activities (not limited to) including internal audits and assessments, GMP inspection readiness, Quality Risk Management and general compliance initiatives.  

 

What You’ll Do:

  • Generates and implements policies and procedures in support of Seres Quality Management
  • Harmonize procedures and processes that ensure compliance with regulations and industry standards.
  • Lead and support GMP readiness activities for new facilities, laboratories and/or support areas.
  • Ensures compliance to internal policies and applicable regulatory requirements
  • Manage and supports inspection readiness efforts for all GxP operations.
  • Coordinate and assist the development of inspection and internal audit responses. 
  • Support supplier qualification activities for all GxP vendors
  • Assist operational areas with development, review and approval support for FMEA, root cause analysis, investigations and other GxP records as required.
  • Provides QA review and approval of CAPA Plans, vendor/supplier approvals and other continuous product and process improvement support.
  • Provides compliance oversight for efficiency improvements based on functional area, site and quality continuous improvement projects.
  • Prepare and review key performance metrics supporting Risk Management, supplier qualification and CAPA programs are conducted per policies and SOPs
  • Perform trending of KPIs to assist QA partners and organization in identifying potential risks and supporting continuous improvement
  • Pro-actively evaluate quality system programs and processes for continuous improvement opportunities.
  • Support Seres GxP Quality System projects, programs and functional area initiatives as required

What You’ll Bring:

  • Bachelor’s degree in life sciences, or engineering with minimum 10 years of experience in the pharmaceutical or biotechnology industry
  • Minimum 2 years of experience in the management of quality systems and compliance.
  • Working knowledge of drug development process and supporting GMP operations
  • Advanced knowledge and demonstrated experience in the applicable GXP regulations, FDA Good Manufacturing and Clinical Practices, ICH Guidelines, Global Drug Development Regulations and Guidance’s and Computer System Validation.
  • Strong verbal and written communication (including presentation) and customer management skills.
  • Ability to work independently or as a team member/leader
  • ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred.
Apply for the Associate Director, Quality Assurance position

Associate Director, Quality

Summary
Reporting to the Director of Quality Assurance, this role will be critical in supporting the growing needs of our Internal Manufacturing and Analytical functions. The Associate Director of Quality will build and lead a team of quality professionals responsible for providing quality oversight of Internal Manufacturing activities which will include batch record review, analytical data review, lot disposition and status changes, support the raw material program and collaborate with CMO management and packaging and labeling teams. This also includes collaborating with External Manufacturing Management to support investigations, CAPA’s and transfer activities. This role will also support PPQ and PAI readiness activities which includes providing quality guidance and support. 


A critical part of this role is to expand quality operations oversight during manufacturing operations which includes collaborating and supporting the Quality teams to ensure clinical supply needs are met. The role is also expected to enable transparency and data driven decision making through the development of KPI's and reporting metrics.

Key Responsibilities

Leadership activities

  • Lead a team of QA professionals to perform and support
  • Batch record reviews during manufacturing operations
  • Provide quality oversight on the manufacturing floor
  • Lot disposition and status changes
  • Deviation investigations and resolution
  • CAPA’s
  • Change controls
  • Attend and participate in all Quality team and leadership meetings.

Staff Development

  • Contributes to annual Talent Management activities: workforce planning, hiring, goal- setting, succession planning, career development and performance management

Business Operations

  • Deep understanding of interconnectedness of operations and able to drive/influence trade-off decisions regarding the allocation of limited resources

Strategic Decision Making

  • Sets department level strategy, ensuring alignment with overall division and company objectives. May contribute to department-level decisions on projects.

Support of daily tasks

  • Perform reviews of internal and external batch documentation, records and reports.
  • Review QC data generated as to the acceptance to established product specifications.
  • Perform lot disposition activities for intermediate and final batches.
  • Partner with members of QA, QC and Manufacturing in batch production activities providing subject matter expertise of general quality items.
  • Partner with internal partners on change controls, investigations and CAPA(s).
  • Perform review of document revisions for internal Manufacturing and Quality groups.
  • Provide guidance and support with resolution of investigations, CAPA and Change Control impacting product disposition.
  • Provides quality guidance and support for manufacturing and quality projects and programs, ensuring compliance with relevant GxP regulations and internal policies.
  • Assist with the resolution of internal audit observations for internal manufacturing and quality teams.
  • Responsible for escalation and resolution of significant quality deficiencies identified in the production process.
  • Assist in the authoring and review of SOPs and applicable policies.
  • Collaborate with Quality teams on streamlining and improving quality processes.
  • Other duties as assigned.

Required Qualifications:

  • Minimum 10 years of well-rounded Quality experience in the pharmaceutical or biotechnology industry.
  • Minimum 3-6  years experience of people management.
  • Demonstrated ability building and leading quality teams with an emphasis on cross-collaboration with improved levels of quality compliance.
  • Experience in FDA pre-approval inspection activities (PAI Readiness).
  • Experience participating in regulatory audits.
  • Experience supporting Process Performance Qualification (PPQ) activities and product transfers.
  • Experience in performing and supporting deviation investigations and developing appropriate CAPA activities.
  • Bachelor of Science degree or equivalent in life sciences or engineering.
  • Experience in providing quality oversight during internal and external manufacturing activities.
  • Experience working in cross functional teams and managing the relationships and expectations of several key stakeholders.
Apply for the Associate Director, Quality Assurance position

Associate Director, Regulatory Affairs, CMC    


The Associate Director of CMC Regulatory Affairs will serve as the leader for execution of CMC regulatory strategy for a new BLA to be filed by Seres. This will include formulating and implementing CMC regulatory tactics for the assembly of Module 3 of the BLA for a unique microbiome platform.  

Primary role includes:

  • Provide CMC RA leadership within RA and on cross-functional CMC teams 
  • Serve as a liaison between the regulatory authorities and the company on CMC issues
  • Maintain up-to-date knowledge and expertise of relevant FDA and ICH guidelines and regulations

Responsibilities

  • Provide CMC regulatory strategy for proposed changes, new development efforts, content message points, or other related activities for development programs.
  • Facilitate timely regulatory approvals of submissions to FDA and other regulatory authorities by ensuring the quality and appropriateness of submission documents, and by ensuring regulatory compliance in submissions
  • Lead the timely preparation of high-quality regulatory submissions including CMC sections of IND, CTA, BLA, MAA, etc. and their amendments/supplements.
  • Serve as a liaison with regulatory authorities for products in the area of Chemistry, Manufacturing and Controls
  • Evaluate manufacturing change controls, assess regulatory impact, and support their implementation.

Education & Experience Requirements

  • B.S / M.S / Pharm. D. or Ph.D. in chemistry, biochemistry, biology, or related pharmaceutical field
  • 8 - 10 years of drug development experience
  • Direct experience in assembling the CMC section of a Major US Marketing Application (BLA, MAA, NDA) for a biologic product.
  • Demonstrated leadership in regulatory strategy and experience in regulatory interactions  

Key Skills and Competencies

  • Excellent interpersonal communication (written and verbal) skills, analytical and organizational skills. 
  • Ability to work successfully with cross-functional teams and influence appropriate plans and actions.
  • Strong attention to detail, establishing priorities, scheduling and meeting deadlines.  
  • Must be able to work in a fast-paced environment with demonstrated ability to effectively manage multiple competing tasks and demands. 
  • Ability to work independently, take initiative and complete tasks to deadlines.
     
Apply for the Associate Director, Regulatory Affairs, CMC     position

Associate Director, Supply Chain (Warehouse, Inventory, Logistics)

Seres Therapeutics is well-positioned to become the first company to bring an approved microbiome drug to patients through our proprietary discovery and design platform.  We identify key alterations in the microbiome that are associated with specific diseases and are designing live bacterial ecologies to act as therapeutics.

The Associate Director is a key position in the Supply Chain and greater CMCQS organizations influencing and collaborating cross-functionally with internal and external partners and will:

  • Manage warehouse, inventory, logistics and personnel in a continuous state of compliance with IATA, DOT, FDA, GMP, SOX and OSHA standards
  • Assess, analyze and optimize warehouse capacity including ambient and temperature-controlled storage locations
  • Implement and maintain inventory programs such as visual reorder point (KANBAN) and Vendor Managed Inventory (VMI) programs for uninterrupted supply of materials
  • Maintain data integrity and accuracy through execution of inventory transactions – receipt through issuance, cycle count and physical inventory
  • Ensure timely material receipt, put-away, picking, issue, and shipments – domestic and international
  • Develop and oversee execution against all SOPs related to receipt, inspection, storage, and delivery of GMP materials
  • Oversee the hiring, training, development, and performance management of Warehouse as well as the establishment of key performance indicators and service level agreements for Warehouse Operations
  • Ensure compliance with ERP and quality systems/processes
  • Maintain GMP warehouse space, coordinating with Facilities for equipment ordering, installation, calibration and maintenance

 

What’s in it for you?

This opportunity is ideal for anyone who possesses excellent verbal and written communication skills and who will drive excellence and collaboration while ensuring adherence to SOX, Trade, IATA, DOT, OSHA and FDA compliance.  The ideal candidate will possess a solid understanding of domestic and international shipping of cold chain products in the Biotech/Lifesciences industry and associated documentation needs; and have a strong working knowledge of and experience with ERP systems (Oracle, SAP, etc.); and GMP warehouse operations.

 

How do you know if you’re the right fit?

This is an incredible opportunity for someone who has proven experience with progressive responsibility in supply chain, warehouse and logistics management and inventory control.  You are excited about leading continuous improvement initiatives within the GMP Warehouse and provide input to broader materials management improvement initiatives.  You are someone who challenges themself with achieving key performance targets for inventory accuracy, timeliness of transactions and closure of quality systems.  You know what it takes to be successful in managing a compliant warehouse and have a vision of and experience with implementing sustainable and robust processes and procedures.  If you are flexible and driven, aren’t afraid of rolling up your sleeves to pitch in, and have managed a GMP Warehouse, implemented raw material programs and processes, achieved a high level of inventory accuracy, you will find this opportunity incredibly engaging. 

Apply for the Associate Director, Supply Chain, Warehouse position

Associate II, Bioprocessing

Why Seres Therapeutics

Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.

Seres Therapeutics is a member of the Flagship Pioneering family of companies.

Job Summary

Building the processes necessary to support these drug programs represents a novel and exciting scientific and engineering challenge, and we are seeking an Associate II, Bioprocessing to join our team. This person will be involved in development of different processes for cell banking and fermentation, as well as novel assays to track upstream and downstream process development. This individual will also collaborate with Manufacturing Sciences to support the transfer of processes to manufacturing operations.  

What You’ll Do

  • Fermenting bacterial cultures to enable cell banking, upstream and downstream process development
  • Participating in novel assay development to support process development
  • Analyzing samples using established protocols and techniques
  • Record keeping and participating in authorship of technical reports
  • Collaborating with other groups at Seres to further shared goals

What You’ll Bring

  • Bachelor’s degree in microbiology, molecular biology, chemical engineering, biotechnology, or a related field, with 2-4 years of industry experience or a master’s degree with 0-2 years of industry experience
  • Experience with anaerobic microbial cell culture and aseptic technique
  • Familiarity with biotech manufacturing processes such as fermentation, filtration, purification, and formulation processes
  • Experience with some of analytical chemistry (HPLC, IC), flow cytometry, DNA sequencing, automation and liquid handling is a plus
  • Ability to plan and execute experiments, analyze data, and present results internally
  • Ability to work well independently or as part of a group
  • Positive attitude and ability to work in a fast-paced environment

Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.  

 

Apply for the Associate II, Bioprocessing position

Job Summary

Seres Therapeutics is seeking an Associate, CMC Manufacturing to join our team who will be responsible for supporting manufacturing operations and clinical supplies across several phases of clinical trials. This individual will be involved in the execution and documentation of cGMP manufacturing processes, and operations pertaining to drug substance and drug product manufacturing. S/he will also ensure proper safety and aseptic protocols for floor operations. This individual will collaborate with multiple support groups such as Quality Control, Quality Assurance, Bioprocess and Facilities to support the transfer of process changes to manufacturing operations.

Job Responsibilities

  • Operation of bioprocess equipment for microbial cultures, recovery and purification
  • Execution of Batch Records and Author Standard Operating Procedures
  • Troubleshooting of manufacturing and process challenges
  • Management of raw materials and consumables required for manufacturing
  • Proactive identification and mitigation of risks
  • Identification of process changes and improvements
  • Initiation and support of deviation/quality event investigations and close-out

Required Skills and Qualifications

  • Bachelor’s degree in Life Sciences or Biotechnology Certificate with 0-1 years ‘experience in Biotech manufacturing
  • Experienced with aseptic techniques
  • Exposure to cGMP standards for clinical and/or commercial manufacturing
  • Knowledge of biotech manufacturing process and equipment in some aspects of fermentation, filtration, purification, and formulation processes
  • Flexible with schedule and willingness to work long shifts if necessary
  • Ability to work in a fast-paced and constantly changing environment to meet current challenges
  • Works well independently and in group settings

 

Apply for the Associate II, Manufacturing position

Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease.  Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.  

Seres Therapeutics is a member of the Flagship Pioneering family of companies. 

What You'll Do

  • Generation of different media to support microbial cell cultures for cell banking and upstream process development
  • Operation of bioprocess equipment for microbial cell cultures to enable cell banking using established protocols and techniques
  • Generation of different consortia of bacteria for in vitro and animal testing
  • Analyzing samples using established protocols and techniques
  • Record keeping and participating in authorship of technical reports
  • Collaborating with other groups at Seres to further shared goals

What You'll Bring

  • Bachelor’s degree in microbiology, molecular biology, chemical engineering, biotechnology, or a related field, with 0-2 years of industry experience
  • Experience with microbial cell culture and aseptic technique
  • Experience with some of high-throughput microbial culture, automation and liquid handling is a plus
  • Ability to execute experiments, analyze data, and communicate results
  • Ability to work well independently or as part of a group
  • Positive attitude and ability to work in a fast-paced and constantly changed environment to meet current challenges

Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.  

Apply for the Associate, Bioprocessing position

Summary

The Donation Operations Associate oversees the activities related to biological sample inventory receipt, characterization, and management under GMP systems.  This position is responsible for inventory management movement and tracking in accordance with GMP guidelines and Seres policies. This position is also responsible for laboratory assays to examine and characterize donor microbiomes.

Responsibilities

  • Maintain an accurate inventory tracking system.
  • Perform laboratory tests, data processing and analyses using various laboratory techniques.
  • Draft and review protocols and Standard Operating Procedures (SOPs) during process development and process improvement activities.
  • Present technical information that pertains to the program as appropriate.
  • Interaction with internal and external stakeholders and vendors in a professional capacity.
  • Management of data analysis and project management tools.
  • Coordinate logistics, supply management and ordering
  • Ability to work in BSL II work environment

Qualifications

 

  • BS with 1-2 years experience
  • Hands-on laboratory experience through either prior work experience or biotechnology-level laboratory course work.
  • Excellent communication and writing skills
  • Strong organization and record keeping skills will be critical for success in this position
  • Experience using project tracking tools desirable
  • Ability to adhere to and execute program SOP’s
  • Proficient in Microsoft suite
Apply for the Associate, Donor Operations position

Bioinformatics Programmer, Bioinformatics & Scientific Computing

Who are we?

Seres Therapeutics is well-positioned to become the first company to bring an approved microbiome drug to patients through our proprietary discovery and design platform. We identify key alterations in the microbiome that are associated with specific diseases and are designing live bacterial ecologies to act as therapeutics. Our research and discovery efforts are elucidating the mechanisms that microbes employ to modulate host immunity and inflammation. The power of the Seres platform has demonstrated therapeutic potential in infectious and inflammatory disease, immune regulation, and immuno-oncology. Seres is conducting multiple clinical trials, including a Phase 3 study of SER-109 to treat multiply recurrent C. difficile infection, a Phase 2b study of SER-287 in ulcerative colitis, and a Phase 1b study in collaboration with the Parker Institute of Cancer Immuno-Therapy to evaluate how treatment with SER-401 can improve response to anti-PD-1 therapy in metastatic melanoma. Our clinical programs provide industry-leading data, driving our preclinical efforts to elucidate how commensal microbes modulate the human immune and metabolic state and guiding our preclinical pipeline of the next generation of microbial therapeutics.

What is in it for you?

The Bioinformatics Programmer in the Bioinformatics & Scientific Computing group will have the opportunity to aid in the design, development, and maintenance of automated frameworks for data delivery, data download, and workflow integration.  You will work within an engineering team to understand user requirements and implement software solutions.  As part of Research and Development, your work will affect every part of drug design, from basic microbiome research to clinical data analysis.  You will be part of a great team that emphasizes collaboration and learning new skills.

Your initial responsibilities will include:

  • Understanding complex microbiome datasets used for ingestion into Elastic or other database systems

  • Developing tools and workflows for transforming NGS and other ‘Omics datasets into actionable outputs

  • Writing software that is reusable, testable, efficient, well architected, and well commented

  • Collaborating with team members to deliver production-ready, rigorously tested software

  • Understanding business needs from team members across R&D functional areas

We seek candidates with these qualifications:

  • Enthusiasm for learning with a team-driven mindset in a diverse, dynamic, and fast-paced environment
  • BS degree or higher in Computer Science, Bioinformatics or a related technical discipline
  • 3+ years of experience in research-and-development setting in bioinformatics
  • Proficiency in Python, Linux shell scripting, and version control tools (git, Subversion)
  • Experience with NGS and other ‘Omics datasets
  • Experience in shared High-Performance Computing (HPC) environments (S/UGE, LSF)
  • Experience with Nextflow workflow framework, R, and scientific data visualization desired
  • Experience with cloud compute infrastructure (AWS, GCP, and/or Azure)
  • Experience with database technologies (SQL, PostgreSQL, Oracle) and Elastic a plus
  • Familiarity with IaaS DevOps tool (Ansible, Terraform)
  • Software containerization experience a plus
  • Knowledge of OOP principles a plus
  • Familiarity with regulatory qualification/validation documentation and testing
  •  
Apply for the Bioinformatics Programmer, Bioinformatics & Scientific Computing position

Director of Marketing

The Director of Marketing will be the HCP professional marketing lead for Seres’ lead asset and potentially the first ever microbiome therapeutic to launch in the US. 

Reporting directly to the VP of Marketing, the Director is responsible for leading development and execution of HCP branded marketing strategy and tactics in preparation for the launch of SER-109 in recurrent C. Dificile infection (rCDI). 

Seres Therapeutics, Inc., (Nasdaq: MCRB) is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres’ SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of rCDI and has potential to become a first-in-class FDA-approved microbiome therapeutic. Seres’ SER-287 program has obtained Fast Track and Orphan Drug designations from the FDA and is being evaluated in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis. Seres is developing SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 for ulcerative colitis and SER-155 to prevent mortality due to gastrointestinal infections, bacteremia and graft versus host disease.

Seres Therapeutics is a member of the Flagship Pioneering family of companies, affording this individual broad exposure and access to other industry leaders in the Flagship fold. 

Seres and the role will be based in Cambridge, MA.   

Responsibilities:

  • Lead and foster collaboration with other brand team members (marketing, sales, analytics, market access, medical affairs, etc.) to develop and execute programs and materials to support best-in-class launch of SER-109 in rCDI
  • Ensure robust and ownable positioning and branding to differentiate SER-109 in the future rCDI market
  • Development of the unbranded and launch branded campaigns, including messaging and effective promotional resources across communication channels to enhance customer engagement
  • Understand key market trends, analytics, and competitive environment to develop market insights critical to product strategy and communication
  • Lead various aspects of conference presence and initiatives
  • Lead efforts to assess and optimize the marketing mix and resource allocation across HCP audiences and identify potential synergies and savings
  • Manage advertising agency and other vendors in development of promotional materials and tactics
  • Develop strong relationships with key opinion leaders and HCP customers
  • Develop and implement best-in-class speaker programs to support field sales efforts
  • Identify value-maximizing and efficient go to market model options for the launch
  • Effectively engage with sales force and handle feedback and field requests
  • Engage in and interpret ongoing market research projects to validate brand positioning and promotional strategy
  • Identify potential operational issues and problem solve
  • Demonstrated project leadership experience
  • Attract, develop, and retain staff members; Inspire and elevate capabilities of others
  • Ensure compliance with corporate policies and procedures, as well as US healthcare laws and regulations

 

Qualifications:

  • Minimum of a bachelor’s degree; advanced degree preferred
  • 10+ years of broad experience in commercial roles with demonstrated progression in marketing; experience in sales and/or market access highly preferred
  • Experience leading campaign development and multichannel planning/execution
  • Recent US launch experience
  • Resourceful, flexible, adaptable, diplomatic, and able to effectively deal with ambiguity
  • Possesses a good blend of strategic and operational experience with the ability to see the big picture and strong attention to detail
  • Experience developing and executing strong strategic plans to support rapid adoption and growth; track record of driving brand performance
  • Fit with Seres culture and values, especially encouraging candidates with diverse backgrounds and those who are inclined to listen as much as they are to decide/lead.    Seres is a highly collaborative environment and, therefore, consensus building will be a critical skill to ensure success in this role
  • Able to translate complex scientific information into clear, concise language, understandable by all audiences, both verbally and in writing
  • Thinks strategically, prioritizes effectively and delivers high-impact results
  • Collaborative leadership skills to influence without authority and work effectively with senior leadership
  • Effectively negotiates and collaborates with stakeholders; demonstrates the ability to resolve conflict in a constructive manner
  • Ability to seek diverse input from multiple constituents and stakeholders to drive decisions and innovative solutions

 

Apply for the Director of Marketing position

Director of Marketing, SER-109

The Director of Marketing is accountable for developing overall commercial strategy for Seres’ lead asset and potentially the first ever microbiome therapeutic to launch in the US. 

Reporting directly to the VP of Marketing, the Director is responsible for leading development of brand strategy and ensuring alignment of functional plans in preparation for the launch of SER-109 in recurrent C. Dificile infection (rCDI). 

Seres Therapeutics, Inc., (Nasdaq: MCRB) is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres’ SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic. Seres’ SER-287 program has obtained Fast Track and Orphan Drug designations from the FDA and is being evaluated in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis. Seres is developing SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 for ulcerative colitis and SER-155 to prevent mortality due to gastrointestinal infections, bacteremia and graft versus host disease.

Seres Therapeutics is a member of the Flagship Pioneering family of companies, affording this individual broad exposure and access to other industry leaders in the Flagship fold. 

Seres and the role will be based in Cambridge, MA.   

Responsibilities:

  • Lead brand planning and commercialization strategy development for SER-109
  • Understand key market trends, analytics, and competitive environment to develop market insights critical to product strategy
  • Determine and size value-maximizing lifecycle management or other evidence generation opportunities for SER-109
  • Work with business insights and analytics to evolve revenue forecasts as required
  • Develop and lead plans to prepare rCDI market for launch
  • Identify and recommend best go to market model for the SER-109 launch
  • Coordinate and drive key work streams which are foundational to brand strategy
  • Specify performance metrics and reporting for key strategic objectives
  • Manage internal review / approval process for promotional launch materials
  • Engage in and interpret ongoing market research projects to confirm prioritized opportunities for brand growth

Qualifications:

  • Minimum of a bachelor’s degree plus MBA or other advanced degree
  • 10+ years of broad experience in commercial roles with demonstrated progression in commercial roles; experience healthcare consulting highly preferred
  • Recent US launch experience highly preferred
  • Resourceful, flexible, adaptable, diplomatic, and able to effectively deal with ambiguity
  • Experience developing and executing strong strategic plans to support rapid adoption and growth
  • Demonstrated ability to think strategically and to assess long term implications of near term decisions and align and engage both internal and external stakeholders to drive performance
  • Ability to work collaboratively with cross-functional teams, synthesizing diverse perspectives into cohesive, aligned recommendation/deliverables, managing dissension along the way and championing team recommendations
  • Fit with Seres culture and values, especially encouraging candidates with diverse backgrounds and those who are inclined to listen as much as they are to decide/lead.    Seres is a highly collaborative environment and, therefore, consensus building will be a critical skill to ensure success in this role
     
Apply for the Director of Marketing position

Why Seres Therapeutics

Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.

Seres Therapeutics is a member of the Flagship Pioneering family of companies.

Position Summary

The Director of Total Rewards of Operations and Systems will ensure that Seres’ compensation, benefits, equity, and other rewards programs are forward-thinking and competitive, support the delivery of our desired employee experience, and align with the Company’s culture and business strategy. You must be comfortable working in a purpose-driven, collaborative culture at both the strategic and tactical levels, thinking longer-term while rolling up your sleeves to execute the details.

What You’ll Do

  • Lead, manage, and administer the compensation and benefits function to ensure programs such as broad-based compensation, equity, bonus programs, recognition, health, and wellness benefits are competitive, valued, and aligned with Seres’ business strategy and financial plans.
  • Identify and propose modifications and enhancements to our total reward programs to address our employees' changing needs and the competitive environment for talent in our industry.
  • Partner with Head of Talent Acquisition on developing offers that are competitive and equitable. Provide guidance on total compensation and equity.
  • Support the Chief People Officer on executive compensation analyses and preparation of materials for the Compensation Committee of the Board of Directors.
  • Partner with Commercial and Finance to design sales incentive plans aligned with Seres’ business objectives and talent strategy while ensuring consistent and market-driven compensation levels.
  • Develop and deliver communications that help our employees appreciate and value their total compensation package benefits, base, bonus, equity, time off, etc.); create total rewards statements and materials.
  • Manage and provide oversight for benefits brokerage Partner for renewal and the open enrollment process, including partnering and negotiating with external vendors, preparing communications for employees, and working with the Chief People Officer to ensure employees are well informed and engaged. Oversee the management and execution of the 401k plan, including all compliance and fiduciary activities.
  • Collaborate with the HR Team and IT to identify technology and system needs that support a growing company. Develop a proposed plan for selecting and implementing applications and systems to enable data-driven decision-making and reduce manual processing. Partner with IT to ensure systems and tools are compatible.
  • Remain current on industry trends, best practices, compliance, new/progressive processes, etc., that enable Seres’ Therapeutics to achieve higher organizational excellence levels.

What You’ll Need

  • BA/BS Degree in Human Resources, Business, or other relevant area is required
  • A minimum of 10 years of diverse experience and progressive responsibility in compensation, benefits, and HR systems and applications, with at least five years in a compensation management role
  • Demonstrated ability to successfully execute in a high growth environment with limited infrastructure.
  • Possess both strategic capabilities with a “roll up your sleeves approach.” This is a leadership position in a small, growing company requiring hands-on execution.
  • Strong project management and prioritization skills to effectively manage and drive multiple projects and initiatives in a fast-paced environment.
  • Strong technical proficiency with HR systems and MS Office tools, including advanced Excel and PowerPoint skills required.
  • Understanding of and experience with equity plans and different types of equity vehicles for publicly traded companies.
  • Expert understanding of SEC, SOX, tax requirements, and all other government regulations apply to compensation, benefits, and equity.

 

Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

Apply for the Director, Total Rewards, Operations and Systems position

Job Summary

Seres Therapeutics is seeking an Engineer, Facilities & Processing to join our dynamic group. Our team is focused on manufacturing therapeutics for the microbiome and ensuring appropriate implementation of new and existing GMP procedures and facility assets to successfully meet manufacturing objectives. This individual will help with managing our manufacturing facilities and equipment, including day-to-day scheduling of vendors and in-house personnel to perform necessary activities, offering technical support in ongoing projects, and development and implementation of cross-functional procedural guidance.  Additionally, this individual will assess current and future manufacturing equipment for fit for use, as well as aid the team in delivering against CQV directives.   S/He will report directly to the Sr Engineer, Facilities & Engineering.

Job Responsibilities

  • Work closely with service vendors and asset owners to conduct full range of equipment and facility acquisition, induction, maintenance, modification, and decommissioning
  • Develop, monitor, and enforce maintenance system requirements, including alarm systems and safety with all service providers
  • Provide troubleshooting and solution guidance when issues in the facility, equipment and systems arise
  • Communicate and collaborate with Manufacturing, Donor Operations, Bioprocess Development and Quality groups to ensure smooth integration of new equipment, maintenance and resolution of emergent conditions
  • Represent the Seres Facilities and Engineering group through internal and external partnerships, emphasizing excellent customer service
  • Monitor alarms during both regular and irregular work hours (as needed)
  • Perform spare parts assessments, implement preventive and corrective maintenance plans, and oversee calibration and metrology programs
  • Assess manufacturing equipment in-house and at Factory Acceptance Tests, perform Commissioning and Validation activities as needed.
  • Provide technical assessments on change controls, deviations, and investigations
  • Identify and analyze project risks and guide working groups to develop appropriate mitigation strategies

Required Skills and Qualifications

  • Bachelor’s degree in Science, Engineering or a related field with 1-5 years of experience
  • Experience working in a highly-regulated environment, particularly biopharmaceutical cGMP procedures
  • Demonstrated strong mechanical aptitude to perform basic troubleshooting and diagnostics for equipment failures
  • Ability to perform Life cycle analysis of manufacturing documents and SOPs
  • Familiar with Standard Operating Procedures, document control, deviations, Corrective and Preventative Actions
  • Experience with calibration and metrology programs (CMMS experiences a plus)
  • Familiar with GMP processing equipment, both fixed and single use. 
  • In-depth knowledge of cGMP requirements for pharmaceutical or biotechnology environment and understanding of biologics manufacturing and/or bioprocess/product development
  • Knowledge of global cGMP requirements and expectations as they pertain to system validation
  • Strong communication skills
  • Detail oriented, independently motivated and possess strong problem-solving abilities

 

Apply for the Engineer, Facilities & Processing position

Why Seres Therapeutics 

Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease.  Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.  

Seres Therapeutics is a member of the Flagship Pioneering family of companies. 

Position Summary 

Seres Therapeutics seeks an experienced Executive Assistant to support the Chief Human Resource Officer and Chief Financial Officer.  The successful candidate will function as a critical member of the HR and Finance teams.  They will take initiative, and proactively address matters with tact, diplomacy and discretion.  The successful candidate has sound judgement, maintains confidentiality and facilitates the effective execution of the CHRO and CFO’s activities.

What you'll do

  • Be a strategic partner, and handle complex, changing calendars.
  • Monitor calendar activity throughout the day, reschedule activities if conflicts arise, provide reminders of upcoming activities to ensure that appropriate time is scheduled to complete tasks.
  • Prepare PowerPoint and other presentations, correspondence and required reporting timely and accurately.
  • Build rapport with CHRO and CFO’s directs and key cross-functional stakeholders.
  • Prioritize, plan, and execute strategic and special projects including events, offsite meetings, team activities, budgets and preparations for senior leadership meetings.
  • Review, proofread, and format internal and external communication to ensure accuracy, consistency and completeness
  • Attend staff meetings, take notes and follow-up on outstanding agenda items
  • Identify issues for escalation and keep in constant communication with others to ensure executive is well informed
  • Provide travel coordination including air and ground transportation, hotel reservations, visas and other travel documentation
  • Provide expense management including compiling receipts to file expense reports and track reimbursement status
  • Monitoring and management of purchase orders and vendor invoices through our PO system
  • Assist in coordination of team all-hands meetings, internal events, off-sites, and all logistical and budget requirements related to the above
  • Must be able to partner with other Executive Assistants in completion of company-wide events
  • Manage vendor and consulting contracts through our contract management system

What you'll bring

  • BA / BS degree or equivalent work experience
  • 7 - 10 years of senior team level support experience
  • Strong attention to detail
  • Strong communication skills and ability to interact with internal and external partners
  • Works well under pressure in a rapidly changing environment
  • Excellent organizational skills and strong follow through on tasks
  • Experience as a problem solver with a genuine interest in learning
  • Exercises sound judgement regarding confidential information
  • Superior computer skills. MS Office Suite is required and using applicant tracking systems and human resources information systems is a plus; ability to gather data, compile information, and prepare reports within Excel

 

Apply for the Executive Assistant to the CHRO and CFO position

Executive Director, New Product Planning

The Executive Director of New Product Planning reports directly to the VP of Marketing and is responsible for leading development of commercial strategy for the portfolio of development stage assets from Seres Therapeutics, the leading microbiome company.  With an initial focus on the Ulcerative Colitis Franchise, the remit of the role includes but may not be limited to:  providing leadership and direction of commercial strategies; ensuring development plans build to a robust differentiated label and reimbursable file; partnering with program teams in assessment of data generation and label expansion plans in support of enhancing commercial value. 

As a member of the Commercial Leadership Team, this position will work across the organization to ensure external stakeholder perspectives are reflected in key deliverables and decisions supporting commercialization plans and clinical development.  

Seres Therapeutics, Inc., (Nasdaq: MCRB) is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres’ SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic. Seres’ SER-287 program has obtained Fast Track and Orphan Drug designations from the FDA and is being evaluated in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis. Seres is developing SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 for ulcerative colitis and SER-155 to prevent mortality due to gastrointestinal infections, bacteremia and graft versus host disease.

Seres Therapeutics is a member of the Flagship Pioneering family of companies, affording this individual broad exposure and access to other industry leaders in the Flagship fold. 

Seres and the role are based in Cambridge, MA.   

Responsibilities:

  • Lead commercial planning for the pipeline products, with an initial focus on the UC franchise, including market and opportunity assessments to inform target product profile development and evolution
  • Evaluate the market landscape, monitor changes, identify market dynamic trends and incorporate competitive intelligence
  • Develop commercial assessments based upon unmet medical need, competitive landscapes, patient flow/pathways and players/drivers in the value chain
  • Work with Market Access and HEOR colleagues to form initial pricing options and strategies for value demonstration and achievement of reimbursable file
  • Lead development of early branding work, including:  initial positioning, brand personality, tradename, and packaging
  • Work cross functionally to enhance opportunity knowledge and support product demand forecasts, scenario assumptions and supply chain planning
  • Serve as commercial representative to program teams. Work in close cross-functional collaboration with clinical development, regulatory, corporate strategy, commercial and other functions
  • Drive development of asset market insight plans in collaboration with project teams, market research, and competitive intelligence; plan and execute advisory boards
  • Establish strong KOL relationships in collaboration with Medical and R&D
  • Point of liaison for current and potential future external partners (e.g. with ex-North American partner Nestle Health Sciences for SER-287 and SER-301) to integrate commercial strategy, where appropriate for partnered assets
  • Attract, develop, and retain potential staff members; inspire and elevate capabilities of others

Qualifications:

  • Bachelor’s degree in business, science or related field. A master’s degree (MBA) strongly preferred
  • 10+ Years of previous biopharmaceutical commercial experience in new product planning, brand marketing for launch and/or in-line products, market access or other commercial functions; some healthcare consulting experience highly preferred
  • Demonstrated ability to think strategically and to assess long term implications of near term decisions and align and engage both internal and external stakeholders to drive performance
  • Ability to work collaboratively with cross-functional teams, synthesizing diverse perspectives into cohesive, aligned recommendation/deliverables, managing dissension along the way and championing team recommendations
  • An approachable and credible communication style, both verbally and written, to keep all levels of the organization informed and engaged
  • Experience in delivering complex messages to various internal and external customers with a track record of effective and influential presentations
  • Ability to understand the science and data; be effective at leveraging analytics and leading within a science-driven commercial mode
  • Strong interpersonal skills with demonstrated ability to drive toward alignment and ability to work well with others and manage work with counterpart(s)
  • Exceptional persuasive written/verbal communication and presentation skills. Willingness to present the facts and put forth hypotheses in the face of differing opinions. Ability to build a logical story flow
  • Fit with Seres culture and values, especially encouraging candidates with diverse backgrounds and those who are inclined to listen as much as they are to decide/lead.    Seres is a highly collaborative environment and, therefore, consensus building will be a critical skill to ensure success in this role
     
Apply for the Executive Director, New Product Planning position

Why Seres Therapeutics

Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.

Seres Therapeutics is a member of the Flagship Pioneering family of companies.

Position Summary

At Seres, we’re leading the microbiome revolution — and our most revolutionary asset is our team. Their courage and deep commitment are what drives us on our mission to transform the lives of patients worldwide with revolutionary microbiome therapeutics

As a highly-motivated Senior or Principal Research Associate you’ll have the opportunity to put your scientific curiosities to work as you design and develop new assays/experiments in a boutique scientific setting.  The decisions you make will have a significant impact on the success of our company.

What You’ll Do

This opportunity allows you to move beyond performing the same assays and experiments day-in and day-out.  You’ll advance your career in an environment where you can learn and run a variety of assays and experiments driven by your creativity, good sense of judgement, innovation (of course), and in-depth knowledge of biology.  You will not get bored in this position!

If you enjoy staying abreast of scientific literature, you’ll find that discussions with your colleagues will go far and you’ll be pleased at how you will integrate that knowledge into your biological screening efforts -across all therapeutic areas.  This position will allow you to research your assays or experiments, put the design to test, interpret the results, and share your finding with internal and external research teams. It’s a highly collaborative and supportive environment.

What You’ll Bring

  • A BS with 8-10yrs of experience and knowledge in the invivo biotech field
  • Invivo mouse model experience and handling including PO, IP, SC dosing, invivo tumor measurements with tissue and blood collection along with necropsy experience.  Assist in sample processing for ex-vivo analysis.
  • Highly skilled in understanding and conducting invivo models required, oncology experience preferred.
  • Protocol/study design experience and data presentation required. 
  • Experience working in a gnotobiotic/germ free facility would be great but not required. 
  • Working experience with IACUC protocols and oversight
  • Proficient with basic computer programs routinely used such as Word, Excel, PowePoint, and GraphPad Prism 

 

Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.  

Apply for the Principal Research Associate – Host Biology Invivo position

Job Summary

Seres Therapeutics is seeking a Principle Associate, CMC Manufacturing to join our team who will be responsible for supporting manufacturing operations and clinical supplies across several phases of clinical trials. This individual will be involved in the execution and documentation of cGMP manufacturing processes, and operations pertaining to drug substance and drug product manufacturing. S/he will also ensure proper safety and aseptic protocols for floor operations. This individual will collaborate with multiple support groups such as Quality Control, Quality Assurance, Bioprocess and Facilities to support the transfer of process changes to manufacturing operations.

Job Responsibilities

  • Prepare raw materials, media culture, solutions and consumables according to Standard Operating Procedures and safety regulations for manufacturing operations
  • Leading and or performing on floor activates
  • Author Standard Operating Procedures, Batch Records, Corrective and Preventative Actions and Deviations
  • Trouble shoot process issues and communicating to supporting teams
  • Participate in investigations and quality events
  • Ensure availability of required materials and equipment for manufacturing operations
  • Follow and complete daily standard operation procedures by completing reports, performing batch records, logging equipment, maintaining safety procedures and reviewing manufacturing documentation to ensure compliance
  • Maintain cleanliness and orderliness of manufacturing facilities
  • Ensure Manufacturing Suite is inspection ready at all times
  • Provide training to and review safety procedures with junior employees
  • Plan production activities within assigned area
  • Adjust activities and resources as needed
  • Perform as Subject Matter Expert or system owner for specific pieces of equipment
  • Model Manufacturing Core Behaviors
  • Collaborate with affected group or individuals to resolve or mitigate effects of an error or abnormality
  • Thoroughly understand the process critical path
  • Provide Manufacturing daily updates
  • Understand how to spread the knowledge/experience and utilize talent of the team members to maintain SME’s across process steps

Required Skills and Qualifications

  • Bachelor's degree in Science, Engineering or a related field with 5-8 years of experience in biopharma clinical manufacturing or relevant industry
  • Previous experience in a cGMP or clinically regulated environment
  • Strong organizational skills and attention to detail
  • Excellent communication skills and strong team player
  • Flexible and adaptable work schedule

 

Apply for the Principle Associate, Manufacturing position

Reporting to the Director of Project Management, the Project Manager will be primarily responsible for managing a major CAPEX project and project teams.  The Project Manager needs an understanding of CAPEX projects from project ideation to project closeout.  Additionally, the ideal Project Manager must possess the technical knowledge and experience to drive tasks to completion for all stages of a CAPEX project. They are accountable for the operational efforts both internally and externally to drive the execution of our project teams.  The Project Manager will work closely with the project sponsorship and team members to achieve project completion on time and on budget.

The Project Manager will be responsible for the creation and execution of complex CMC development and pharmaceutical operations plans. The Project Manager will lead a team and will work closely with subject matter experts in drug development, analytical development, technical operations and supply chain. Project Manager will be responsible for comprehensive communication, including status reporting, risk management and escalation of issues to cross-functional stakeholders and Senior Management. Project Manager will assist in the creation of processes to streamline project management and be accountable for project development, timelines and pharmaceutical operations teams. The Project Manager will become a key resource for the team, providing input on content, advice, and leveraging his or her in-depth experience executing pharmaceutical manufacturing projects.

  • Authors request for proposal packages
  • Engages service providers (CMOs, Engineering/CQV firms, etc) to communicate company needs
  • Reviews proposals for CAPEX work and confirm proposals meet Seres' needs
  • Facilitates meetings with internal and external stakeholders to develop project goals
  • Secures buy in from key company stakeholders regarding project scope, schedule and budget
  • Manages CAPEX projects with assistance from Seres or contract resources
  • Contributes to development of clear standards for project workstreams which can be used across functions
  • Provides periodic reports and updates on project status to key company stakeholders
  • Delivers projects with completed scope, on time and on budget.
  • Supports the project team to shape and execute the project strategy, working with the project sponsorship
  • Establishes a close partnering relationship with each team member. Contributes to a high-energy team spirit and high functioning team
  • Maintains detailed, rigorous timelines for each project and brings an attitude that “every day counts”. Tracks the various parts of the timeline, resolves issues, and updates timeline on an on-going basis to allow transparency
  • Develops and coordinates resource planning across functions
  • Responsible for the conduct and deliverables of project team meetings
  • Identifies project risks with input from team members, and works to resolve
  • Ensures all decisions made at the project team meeting are assessed as to their impact – positive, negative or neutral on the current plan, budget, and available resources

 

 Qualifications

  • Bachelor's Degree in Engineering, Biochemistry, Microbiology or other related discipline (required)
  • Master's Degree in Engineering, Biochemistry, Management or other related discipline (desired)
  • 3-5 years experience in Pharmaceutical CAPEX projects (required)
  • Demonstrated expertise in Pharmaceutical project management
  • PMP certification (desired)
  • Strong prioritization skills
  • Effectively utilizes information technology systems and project management tools and systems
  • Demonstrated ability to work well with others within and across functions/teams
  • Able to lead / manage parts of a project autonomously
  • Able to influence project team decisions and challenge team member recommendations
  • Strong communication skills both written and verbal; skilled in writing project documentation; able to foster open communication; possesses good conflict resolution skills
  • Ability to distill information from team meetings, governance presentation topics, etc., and synthesize the information into a coherent story for the audience as appropriate.

 

Apply for the Project Manager position

Why Seres Therapeutics

Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.

Seres Therapeutics is a member of the Flagship Pioneering family of companies.

Scientist I - Formulation Development:

We are seeking a highly motivated Scientist to assist in formulation development for microbiome therapeutics.  The scientist will design and develop novel, oral formulations intended to maximize the efficiency of live biologics to the GI tract.  For this multidisciplinary role, the scientist will work with a creative, collaborative team of motivated scientists in pharmaceutical science, bioprocess development, analytical development, immunology, microbiology, and microbiome research.  Responsibilities will include formulation screening (oral suspensions and dry powders), formulation development (QbD), process development (lyophilization, milling, blending), process ranging studies and analytical characterization (light scattering, SEM, density measurements, flow analysis, dissolution, disintegration, sedimentation time, rheology).  The position will also work with manufacturers to perform feasibility assessments of innovative unit operations and novel enteric technologies.

What You’ll Do

  • Development and physicochemical characterization of oral suspension and dry powder formulations
  • Development of small-scale in vitro screening techniques to predict formulation performance
  • Independent experimental design (DoE), execution, and troubleshooting
  • Process ranging studies to suppor, scale-up and process transfer
  • Feasibility assessments of new process technologies
  • Data analysis and written and oral presentation of results
  • Contribution to a safe and compliant laboratory work environment

What You’ll Bring

The candidate must be a strong team player with excellent communication skills working in a complex cross-functional matrix.  The candidate must be able to work independently and take initiative.  The candidate must be intellectually curious and show resilience in solving complex problems.  This candidate will show the courage to take risks and follow through to completion.

Education Minimum Requirement:

  • PhD in pharmaceutical science, chemical engineering, biological engineering, biochemistry, or related field.  Recent graduate with 0-2 years of industry experience. 
  • Experience in formulation development and advanced drug delivery technologies, with an emphasis on oral suspension and dry powder dosage forms
  • Experience with powder handling unit operations (lyophilization, milling, blending)
  • Strong analytical skills and experience in physicochemical characterization techniques such as light scattering, SEM, density measurements, flow analysis, dissolution, disintegration, sedimentation time, rheology
  • Understanding of oral absorption and GI physiology in humans and relevant preclinical species
  • Superior verbal & written communication skills
  • An excellent record of academic achievement, including publications in peer-reviewed journals
  • Strong personal character and ethics

 

Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

Apply for the Scientist I, Formulation Development position

Scientist, Analytical Development 

Seres Therapeutics is well-positioned to become the first company to bring an approved microbiome drug to patients through our proprietary discovery and design platform.  We identify key alterations in the microbiome that are associated with specific diseases and are designing live bacterial ecologies to act as therapeutics in areas as diverse as infectious and inflammatory disease, immune regulation, and immuno-oncology.

The Scientist, Analytical Development will work closely with our Analytical Development, Quality Control, and Research & Development teams in the development of microbial and molecular assays to ensure safe and effective bacterial therapeutics for the patients who need them.  This is a fantastic opportunity for a creative scientist who can apply their expertise to the unique challenges faced when characterizing and releasing therapeutics comprised of communities of bacteria. 

 

What’s in it for you?

This is an opportunity to have a significant impact on the development of a novel class of therapeutics for various disease areas while learning about the exciting science of the microbiome and its impact on human health and disease.  

 

How do you know if you’re the right fit?

This is an incredible opportunity for someone who will get excited about developing assays that are robust and capable of supporting key decisions to move our programs forward.  If you are flexible and driven, have worked in a fast-paced organization, and enjoy the challenge of forging a path forward in a new field, you would find this novel opportunity very engaging.  

In order to develop the sorts of assays Seres needs, you should be a PhD-level scientist, or equivalent, with significant assay development experience in the area of molecular biology and/or microbiology.   You should have an excellent attitude with an infectious excitement around learning and teaching your craft.   Experience with assay qualification or validation is a plus. Other desirable skills include sequencing, qPCR/dPCR, probe-based hybridization assays, LC-MS, IC, and automated liquid handlers.

Apply for the Scientist, Analytical Development position

Senior Attorney, Corporate Counsel 


The Senior Attorney, Corporate Counsel is responsible for leading public company reporting, managing corporate governance of Seres and its subsidiaries, and advising and structuring corporate and employee securities and financing transactions. The Senior Attorney, Corporate Counsel will also be given the opportunity to broaden their skills relating to areas such as licensing and other transactional activities, healthcare law and employment law. 

The ideal candidate would have 2-5 years of experience at a top law firm focused on life sciences companies, and/or in-house at a biopharmaceutical company, and be capable of overseeing SEC reporting and corporate governance areas with limited oversight.

This individual will report to the Assistant General Counsel at a time when Seres is preparing for the commercial launch of its first product candidate, SER-109, a likely first-in-field microbiome therapeutic product. This individual will have the opportunity to work directly with, and provide advice to, senior management and the board of directors on key corporate legal issues, and drive business growth in preparation for and during commercial launch.  

Seres Therapeutics, Inc., (Nasdaq: MCRB) is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres’ SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic. 

Seres Therapeutics is a member of the Flagship Pioneering family of companies, affording this individual broad exposure and access to other industry leaders in the Flagship family of companies.

RESPONSIBILITIES

  • Ensuring compliance with and collaborating with team members to draft disclosures required by SEC and Nasdaq (e.g., 10-Ks, 10-Qs, 8-Ks, Proxy Statements and Section 16 filings);
  • Supporting the Investor Relations team, including preparing forward looking statements for presentations and press releases;
  • Assisting with matters related to equity incentive awards 
  • Assisting with corporate governance matters, including preparing board and committee resolutions and minutes;
  • Forming new entities and maintaining and updating all minute books and share records for all entities; 
  • Assisting  in drafting, negotiating, and interpreting commercial agreements and other corporate contracts with strategic and collaboration partners, academic institutions, CROs, vendors and other third parties
  • Handling other day-to-day legal matters including employment law, healthcare law, and other operational matters, financings and corporate governance, and liaise with outside counsel on such issues as appropriate

EDUCATION OR CERTIFICATION REQUIREMENTS

  • Graduate of a top law school accredited by the American Bar Association
  • J.D. 

PROFESSIONAL WORK EXPERIENCE

  • 2-5+ years of experience with corporate securities / public company reporting
  • Experience with biopharmaceutical and/or life sciences industry
  • Major law firm or in-house counsel experience in biopharmaceutical and/or life sciences industry a plus
  • Experience with biopharmaceutical licensing transactions a plus
  • Experience with SEC reporting and corporate governance areas.

QUALIFICATIONS AND SKILLS

  • Ability to understand legal and business issues quickly, exercise sound judgment, and provide practical, hands-on, business-oriented legal advice and solutions
  • Works well with others and interacts comfortably with associates across departments and job levels
  • Ability to develop trust-based and collaborative negotiating and working relationships with internal and external partners (CROs and other service providers and current and potential future biopharma partners)
  • Candidate would be a problem solver who takes responsibility for projects, identifies and solves issues independently, and provides practical solutions and legal analysis.  Curiosity, flexibility and a good sense of humor also plusses. 
Apply for the Senior Attorney, Corporate Counsel  position

What’s in it for you?

You’ll be the glue that holds our clinical programs together in many ways. You will use your strategic insights to provide scientific support for many clinical activities, and help us build clinical expertise in new therapeutic areas. Forming close partnerships with clinical operations, you’ll employ your expertise to mentor and train new medical monitors (MDs) how to write protocols and how to present medical data in a concise, consistent, and compelling manner. You will assist them by writing draft manuscripts (paper, abstracts, posters, etc.) review and summarize relevant literature. With your knowledge of clinical drug development, you’ll have a tremendous impact as you contribute to the creation and maintenance of clinical development plans ultimately leading to critical decision points for our key trials. Additionally, you’ll report to the Chief Medical Officer and collaborate closely with clinical monitors, clinical operations, program management, biostatistics, and data management.

How do you know if you’re the right fit?

With your comprehensive understanding of the drug development process in all phases of testing, you’ll enjoy contributing to the clinical strategy and creation of the clinical development plans while working as part of an integrated team. You’ll desire to identify and cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors. Your experience in providing support to advisory boards, consultant meetings and investigator meetings (including preparation and delivery of presentations) will come in handy. You will have great references that can attest to your skill at collaborating with the clinical development team on the review, analysis, and interpretation of study results; and, most importantly, your ability to author clinical sections of regulatory documents such as INDs, Investigator Brochures, CTAs, ISE’s, Clinical overviews, Health Authority responses, PSUR, and DSUR is impeccable. You’ll also be someone who gets excited about data! You’ll love to make sure it’s accurate, timely, and be able to use it to articulate a compelling scientific story.

The other stuff

This is typically a role best suited for an MS, PhD or PharmD, or equivalent with clinical research experience and a strong knowledge of drug development. You’ll need at least 3 - 5 years of experience in planning, reporting and publishing clinical studies, a strong scientific background with industry clinical research experience. Most helpful in your success is a thorough understanding of ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (clinical ops, reg, QA) and clinical investigators. You may be traveling up to 10% of your time. This great opportunity requires you to have superb verbal and written skills.

 

 

Apply for the Senior Clinical Scientist position

Senior Director, Biostatistics

Why Seres Therapeutics
Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease.  Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.

Seres Therapeutics is a member of the Flagship Pioneering family of companies.

Position Summary
At Seres, we’re leading the microbiome revolution — and our most revolutionary asset is our team. Their courage and deep commitment are what drives us on our mission to transform the lives of patients worldwide with revolutionary microbiome therapeutics

Reporting to the Chief Medical Officer,  you will provide statistical leadership and expertise in support of the clinical development of Seres' products. The successful candidate will provide leadership and guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. The Senior Director, Biostatistics will participate in regulatory interactions and submissions to the FDA and other regulatory agencies and contribute to the biometrics effort across the different programs to identify, develop and implement departmental standards, applications, processes, and training.

What You’ll Do

  • Apply complex and innovative statistical approaches to your work (e.g. modeling and simulation, adaptive design/Bayesian statistics)
  • Provide interpretive and analytical publication support, safety surveillance, pharmaco-economic initiatives and statistical consulting advice to other functions as needed
  • Provide guidance and direct input in addressing any statistical issues from regulatory, legal or other challenges to the company's products or processes and represents the biostatistics of the company in key regulatory meetings
  • Contribute strategically to clinical development plans, regulatory strategies, and life cycle planning to ensure that the company's clinical programs are optimally designed and executed
  • Assists in the development of study protocols, provides sample size estimates and power calculations for complex study designs, and oversees generation of randomization schedule for complex randomization schemes
  • Develops statistical analysis plans for studies, performs complicated statistical analyses, and oversees the generation of tables, listings and figures for study reports and manuscripts
  • Demonstrates proficiency with SAS statistical procedures, familiarity with specialized statistical software (e.g.,R, S-PLUS, EaSt)
  • Lead in developing department standards and research in advanced statistical methodologies

What You’ll Bring

  • PHD in Biostatistics or Statistics with 10+ years of pharmaceutical, biotechnology or equivalent experience, or Masters in Biostatistics or Statistics with 14+ years of pharmaceutical, biotechnology or equivalent experience
  • Comprehensive knowledge of statistical theory and methods and demonstrated ability to apply it in designing data acquisition trials, assessing results, analyzing trend
  • Led NDA/BLA/MAA activities from a statistics perspective and experienced in direct regulatory interaction and experienced in regulatory inspections
  • Expertise in SAS programming including statistical analysis, data manipulation and scientific graphing
  • Prior experience communicating with and presenting to the US FDA and European Regulatory Authorities
  • Demonstrated knowledge of all relevant statistical regulatory guidance and standards (e.g. FDA, ICH and EMEA)
  • Experience in oversight/management of biostatistical services provided by CROs and/or contractors

Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

Apply for the Senior Director, Biostatistics position

Seres is seeking a Senior Director, Commercial Regulatory  to lead the advertising, promotional, and labelling activities for multiple products across their diverse portfolio.  The chosen candidate will have the opportunity to break new ground and be part of filing and potential launch for the first microbiome therapeutic in the United States.

The person will be responsible for providing strategic guidance on the development and implementation of a creative and compliant labeling, advertising and promotion program for pre-launch and commercial microbiome portfolio. She/he will work with limited supervision to review and provide strategic advice on advertising & promotion materials, in accordance with the requirements of the US Food and Drug Administration (FDA), company policy, and business goals and objectives. He/she will also ensure effective communication and constructive working relationships with regulatory authorities and internal/external collaborators.

 

Responsibilities

  • Serves as the primary regulatory advertising and promotion reviewer on cross-functional Promotional Review Boards (PRB) for the successful launch of the company’s commercial programs, and on Medical Review Boards (MRB) for the compliant scientific exchange of information of investigational programs.
  • Acts as primary contact with FDA’s Office of Prescription Drug Promotion (OPDP), including responding to agency inquiries and managing company requests for advisory review.
  • Develops solutions to complex US promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively managing business risks.
  • Identifies and provides guidance on development and improvement of policies, processes, and standards for promotional materials and related activities.
  • Works closely with Regulatory counterparts to ensure that global development strategies result in commercially viable labeling, in support of desired promotional claims.
  • Participates in training of personnel on advertising and promotional materials, as required.
  • Provides oversight to relevant external vendors and consultants, particularly as it relates to ex-US advertising and promotional activities.
  • Monitors and keeps organization up-to-date on US regulatory promotional environment (e.g., the issuance of new FDA regulations/guidance, relevant FDA enforcement action and general awareness of industry practices, including those of competitors).
  •  

    Qualifications

  • BA/BS Degree required.
  • Advanced degree preferred (MS, PhD, PharmD, or JD).
  • Significant years of pharmaceutical industry experience, with experience focused on the regulatory review of advertising and promotion materials for prescription drug products.
  • Experience with launching new products and/or new indications a must
  • Direct experience interacting with OPDP required.
  • Experience working on an accelerated approval product a plus.
  • Strong interpersonal and oral and written communication skills.
  • Able to innovate, analyze, and solve problems with minimal supervisory input, anticipating and identifying regulatory risks and making recommendations to management, as appropriate.
  • Solid understanding of business goals and common marketing concepts/tools, including the internet and social media.
  • Experience in managing multiple global programs a plus
Apply for the Senior Director, Commercial Regulatory Strategy position

Seres is seeking a Regulatory Strategy Leader for multiple products across their diverse portfolio.  The chosen candidate will have the opportunity to break new ground and be part of filing and potentially winning approval for the first microbiome therapeutic in the United States as well as other markets.   

The Sr Director Regulatory Strategy will have a key role contributing to build a successful clinical regulatory strategy function at Seres and will lead key interactions between Seres and the FDA. The role includes participation in defining and implementing the strategy from first-in-human trial until marketing authorization and subsequent adjustments. 

The Sr Director Regulatory Strategy will be responsible for ensuring alignment on regulatory strategy, activities, and timelines between project, product, and program teams. A successful Senior Director of Regulatory Affairs will build effective partnerships with counterparts across the R&D organization, as well as external partners. 

Responsibilities:

The areas of responsibilities will include

  • Participate in the redefinition of the regulatory strategy for the company.
  • Provide regulatory support in preparation of documents such as Investigator Brochure, clinical study protocols, and Informed Consent.
  • Provide regulatory advice to all stakeholders in support of the development of clinical study reports.
  • Plan and supervise preparation and filing of regulatory submissions for assigned products/programs from IND to NDA/BLA as well as Fast Track, Breakthrough, RMAT, and ODD to US agencies and institutions.
  • Plan, supervise, and represent Seres at regulatory agency meetings.
  • Interpret and explain regulatory agency communications to stakeholders across Seres’  program/project teams to ensure accurate functional area responses to agency requests and comments.
  • Represent Seres on co-development teams and liaison with co-development partners on regulatory planning and strategy.
  • Participate in building the Regulatory Affairs team.
  • Stay current on changing regulatory environment, advise Seres on new and changing regulations that may impact ongoing development programs, and work with QA to implement new or changed operating procedures for ongoing programs.
  •  

    Requirements:

  • Industry Experience:
    • Significant experience in regulatory affairs within the biotech or pharmaceutical industry, including direct experience interacting with the FDA; experience with CBER preferred. Experience with foreign regulatory agencies a plus.
    • Experience with US regulatory submissions, Orphan Drug Designation, Rolling BLA, Fast Track and Breakthrough therapy designations in the US  as well as foreign agency equivalents considered a plus.
    • Experience planning and managing complex regulatory submissions.
    • Regulatory or scientific experience across a variety of disease areas considered a plus.
    • Experience collaboratively developing Target Product Profiles is required.
    • Experience developing and implementing a Clinical Development Plan is required.
    • Experience working with external medical/scientific experts to support development planning and strategy.
  • Critical Skills:
    • Strategic problem-solving skills.
    • Excellent organizational and multitasking abilities.
    • A team player with leadership skills.
    • Superior communication skills.
    • Scientific curiosity strongly preferred
Apply for the Senior Director, Regulatory Strategy position

Senior Engineer, Downstream Bioprocessing

Why Seres Therapeutics

Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.

Seres Therapeutics is a member of the Flagship Pioneering family of companies.

Job Summary

Seres Therapeutics is seeking a highly motivated Senior Engineer, Downstream Processing to join our Bioprocessing team. We are focused on developing and supporting manufacturing processes to enable cGMP manufacturing of Seres Therapeutics’ pipeline products. In the role you will be leading the downstream process development of different drug substance and drug product manufacturing processes and work closely with various groups, including Manufacturing Sciences and Technology, Manufacturing Operations, Analytical, Formulation Development, Regulatory, Quality Control, and Quality Assurance.

What You’ll Do

  • Responsible for development of different downstream process unit operations for different phases of clinical programs
  • Responsible for new process scale-up, process optimization, technology transfer and process validation activities.
  • Serve as technical expert for the drug substance and drug product downstream manufacturing processes.
  • Manage timelines and deliverables from project ideation through completion.
  • Manage associates and/or downstream engineers
  • Author and execute experiments for process development, characterization, & scale up following the principles of Quality by Design (QbD).
  • Provide technical support for GMP manufacturing runs.
  • Perform process performance analysis and trend process performance.

What You’ll Bring

  • BS or MS degree in Biomedical Engineering, Chemical Engineering, Mechanical Engineering or related technical discipline.
  • BS with 8+ years of industrial experience or MS with 6+ years of industrial experience in manufacturing sciences, downstream process development, or related field for Senior Engineer and BS with 5+ years of industrial experience or MS with 3+ years of industrial experience in similar field for Engineer II.
  • Prior experience with some or all of the following: single-use purification systems, tangential flow filtration, continuous centrifugation
  • Prior experience with tech transfer, risk assessments, and quality systems in GMP environment.
  • Experience with writing and reviewing technical reports
  • Familiar with FDA and EU regulations and GMP standards.
  • Experience with anaerobic systems is a plus
  • To be successful, you will possess sound understanding of engineering fundamentals, be independently motivated, able to work under aggressive timelines to achieve meaningful objectives, comfortable in a dynamic environment, detail oriented, and possess creative problem-solving abilities.
  • We are looking for a person who meshes well with our culture – eager to dig into whatever work is needed, with a quick learning curve, and do so with high quality results. Collaboration and communication with laboratory and manufacturing colleagues is key!

Seres is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

 

Apply for the Senior Engineer, Downstream Bioprocessing position

Senior Engineer, MSAT – Early Phase

Seres Therapeutics is a dynamic biotechnology company in Cambridge MA pioneering innovative Ecobiotic® microbiome therapeutics. Seres has promising late clinical stage programs and is well-positioned to become the first company to commercialize a new therapeutic modality comprising ecologies of commensal bacteria. Seres plans to enter the clinic with multiple new product candidates in a range of therapeutic areas including infectious disease, inflammation and metabolic disease and to build upon its field-leading portfolio of intellectual property and know-how.

Job Summary

Seres Therapeutics is seeking a highly motivated Senior Engineer to join our Manufacturing Sciences & Technology team. We are focused on developing and supporting manufacturing processes to enable cGMP manufacturing of Seres Therapeutics’ pipeline products.  The successful candidate will take a lead technical role in the identification and implementation of continuous improvements aimed at consistency and robustness, working closely with Manufacturing Operations to ensure robust, compliant cGMP manufacturing performance. In the role you will work closely with various groups, including Bioprocess Development, Manufacturing Operations, Facilities & Engineering, Supply Chain, Regulatory, Quality Control, and Quality Assurance.

This role will be responsible for ensuring a robust, scalable and efficient manufacturing processes to produce late-phase clinical trial drug.

Responsibilities

  • Responsible for new product scale-up, process optimization, technology transfer and process validation activities.
  • Serve as technical expert for the drug substance and drug product manufacturing processes.
  • Project leadership:  manage timelines and deliverables from project ideation through completion.
  • Facilitate criticality and risk assessments for manufacturing processes and raw materials, soliciting and incorporating feedback from the appropriate SMEs.
  • Author and execute experiments for process development, characterization, & scale up following the principles of Quality by Design (QbD).
  • Provide technical support for GMP manufacturing runs, supporting manufacturing through quality systems; deviations, CAPAs, & change controls.
  • Make decisions regarding product impact
  • Maintain manufacturing performance metrics. Regularly review and assess manufacturing performance.

Required Skills and Qualifications

  • BS or MS degree in Biomedical Engineering, Chemical Engineering, Mechanical Engineering or related technical discipline.
  • BS with 6 years minimum, 8+ preferred of experience or MS with 5+ years of experience in manufacturing sciences, process development, process validation, or related field.
  • Prior experience with tech transfer, risk assessments, and quality systems in GMP environment.
  • Expert in single-use systems, tangential flow filtration, fermentation, lyophilization.
  • Working knowledge of industry standard practices, FDA and EU regulations and GMP standards.
  • Working knowledge of statistical analysis methods.
  • To be successful, you will possess sound understanding of engineering fundamentals, be independently motivated, able to work under aggressive timelines to achieve meaningful objectives, comfortable in a dynamic environment, detail oriented, and possess creative problem-solving abilities.
  • We are looking for a person who meshes well with our culture – eager to dig into whatever work is needed, with a quick learning curve, and do so with high quality results. Collaboration and communication with laboratory and manufacturing colleagues is key!

 

 

Apply for the Senior Engineer, MSAT - Early Phase position

Senior Engineer, MSAT – Late Phase & Commercial

Seres Therapeutics is a dynamic biotechnology company in Cambridge MA pioneering innovative Ecobiotic® microbiome therapeutics. Seres has promising late clinical stage programs and is well-positioned to become the first company to commercialize a new therapeutic modality comprising ecologies of commensal bacteria. Seres plans to enter the clinic with multiple new product candidates in a range of therapeutic areas including infectious disease, inflammation and metabolic disease and to build upon its field-leading portfolio of intellectual property and know-how.

Job Summary

Seres Therapeutics is seeking a highly motivated Senior Engineer to join our Manufacturing Sciences & Technology team. We are focused on developing and supporting manufacturing processes to enable cGMP manufacturing of Seres Therapeutics’ pipeline products.  The successful candidate will take a lead technical role in the identification and implementation of continuous improvements aimed at consistency and robustness, working closely with Manufacturing Operations to ensure robust, compliant cGMP manufacturing performance. In the role you will work closely with various groups, including Bioprocess Development, Manufacturing Operations, Facilities & Engineering, Supply Chain, Regulatory, Quality Control, and Quality Assurance.  This role will be responsible for scale up of late stage manufacturing processes, process validation and continuous improvement.

Job Responsibilities

  • Responsible for new product scale-up, process optimization, technology transfer and process validation activities.
  • Serve as technical expert for the drug substance and drug product manufacturing processes.
  • Project leadership:  manage timelines and deliverables from project ideation through completion.
  • Author and execute experiments for process development, characterization, & scale up following the principles of Quality by Design (QbD).
  • Provide technical support for GMP manufacturing runs, supporting manufacturing through quality systems; deviations, CAPAs, & change controls.
  • Make decisions regarding product impact.
  • Maintain manufacturing performance metrics. Regularly review and assess manufacturing performance.

Required Skills and Qualifications

  • BS or MS degree in Biomedical Engineering, Chemical Engineering, Mechanical Engineering or related technical discipline.
  • BS with 6 years minimum, 8+ preferred of experience or MS with 5+ years of experience in manufacturing sciences, process development, process validation, or related field.
  • Prior experience with tech transfer, risk assessments, and quality systems in GMP environment, preferably with commercial or licensed products
  • Expert in single-use systems depth and tangential flow filtration
  • Working knowledge of industry standard practices, FDA and EU regulations and GMP standards.
  • Working knowledge of statistical analysis methods.
  • To be successful, you will possess sound understanding of engineering fundamentals, be independently motivated, able to work under aggressive timelines to achieve meaningful objectives, comfortable in a dynamic environment, detail oriented, and possess creative problem-solving abilities.
  • We are looking for a person who meshes well with our culture – eager to dig into whatever work is needed, with a quick learning curve, and do so with high quality results. Collaboration and communication with laboratory and manufacturing colleagues is key!

 

Apply for the Senior Engineer, MSAT - Late Phase & Commercial position

Senior Manager, Donation Collection Facility (DCF)

Seres Therapeutics is well-positioned to become the first company to bring an approved microbiome drug to patients through our proprietary discovery and design platform.  We identify key alterations in the microbiome that are associated with specific diseases and are designing live bacterial ecologies to act as therapeutics.

The Senior Manager, Donation Collection Facility will work closely with the manufacturing, scientific and quality assurance teams to drive biologic material procurement in support of C. difficile patients.  This is a business-critical position; the impact you have on Seres as a key contributor is tremendous.  This is a fantastic opportunity for a very experienced professional with strong experiences in operational management and oversight of a novel biologics procurement program.    

What’s in it for you?

You’ll learn all about our microbiome research and gain an understanding of the biology of specific microbes and the composition of the microbiome in healthy and diseased individuals that allows us to identify “keystone” organisms and functional pathways whose absence or over-abundance may be driving a particular form of dysbiosis.  Learn that our Ecobiotic® drugs are compositions of commensal microbes that are designed to catalyze the transition to a healthy ecology of the microbiome and treat serious human conditions including inflammatory, metabolic, and infectious diseases.  In a nutshell, come to Seres and put your many years of experiences to great use while learning something different that is beyond exciting.

How do you know if you’re the right fit?

This is an incredible opportunity for someone who will get excited about leading the charge on a unique program in support of a pioneering new therapeutic.  You are someone who challenges himself/herself on meeting operational milestones with seamless execution and within established budgets and quality assurance parameters.  You know what it takes to be successful managing operational sites and teams and have demonstrated full competence in continual process improvement and documentation development.

If you have worked in an organization where you managed the procurement of donor derived products, plasma, or blood products, or have experience in facility design and management, you would find this novel leadership opportunity incredibly engaging.

Apply for the Senior Manager, Donation Collection Facility (DCF) position

Why Seres Therapeutics 

Seres Therapeutics is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease.  Our SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.  

Seres Therapeutics is a member of the Flagship Pioneering family of companies. 

Position Summary  

At Seres, we’re leading the microbiome revolution — and our most revolutionary asset is our team. Their courage and deep commitment are what drives us on our mission to transform the lives of patients worldwide with revolutionary microbiome therapeutics 

The Senior Scientist, Molecular Technologies will drive the development and implementation of both classic and novel molecular and genomics methods to support the discovery and development of microbiome therapeutics. 

What You'll Do

  • Oversee the design, development, qualification, and execution of molecular-based assays to support the characterization of complex microbial communities and defined compositions of microbes as well as molecular characterizations of host response to microbiome perturbations. 

  • Develop and use qualitative and quantitative assays to define parameters of sample preparation and NGS library construction steps for a broad range of clinical and non-clinical samples.

  • Work directly with our bioinformatics and microbiome sciences groups to understand how various sequencing methodologies and library construction workflows directly impact gut microbiome characterization and our in-house data analysis pipelines.

  • Work both internally and externally with vendors as a subject matter expert in the field.

  • Integrate closely with the Molecular Technologies team on collaborative projects; sample or data hand-offs; and shared laboratory, planning, and tracking activities.

  • Collaborate closely with the Molecular Technologies, Computational Microbiome Sciences, Bioinformatics, Clinical, and Quality groups to develop, prototype, and qualify molecular- and genomic-based QC and clinical assays.

  • Stay current with literature to enable the company to stay abreast of the most recent developments in genomic and other relevant methods for the characterization of microbial strains and communities.

  • Represent Molecular Technologies in cross-functional R&D program, platform, or incubator teams.

What You'll Bring

  • 5+ years post-graduate experience developing and performing molecular techniques, including but not limited to short-read sequencing (e.g. Illumina) and/or long-read sequencing (ONT or Pacbio), PCR/qPCR, Nanostring, FISH, or similar assays, preferably in a biotech or pharma setting.

  • Experience working with and/or integrating laboratory automation to scale up molecular processes preferred.

  • Demonstrated strong organizational and interpersonal skills, effective communication skills, rigorous quantitative approach, and keen attention to detail

  • Enthusiasm for a team-driven mindset in a diverse and dynamic environment

  • Ability to work independently and take initiative in a highly dynamic environment

  • Previous management/supervisory experience a plus.

  • Ph.D. in Molecular biology, Biochemistry, Microbiology, or a related field

Apply for the Senior Scientist, Molecular Technologies position

System Engineer, Bioinformatics & Scientific Computing

Who are we?

Seres Therapeutics is well-positioned to become the first company to bring an approved microbiome drug to patients through our proprietary discovery and design platform. We identify key alterations in the microbiome that are associated with specific diseases and are designing live bacterial ecologies to act as therapeutics. Our research and discovery efforts are elucidating the mechanisms that microbes employ to modulate host immunity and inflammation. The power of the Seres platform has demonstrated therapeutic potential in infectious and inflammatory disease, immune regulation, and immuno-oncology. Seres is conducting multiple clinical trials, including a Phase 3 study of SER-109 to treat multiply recurrent C. difficile infection, a Phase 2b study of SER-287 in ulcerative colitis, and a Phase 1b study in collaboration with the Parker Institute of Cancer Immuno-Therapy to evaluate how treatment with SER-401 can improve response to anti-PD-1 therapy in metastatic melanoma. Our clinical programs provide industry-leading data, driving our preclinical efforts to elucidate how commensal microbes modulate the human immune and metabolic state and guiding our preclinical pipeline of the next generation of microbial therapeutics.

 

What is in it for you?

The System Engineer in the Bioinformatics & Scientific Computing group will have the opportunity to aid in the maintenance and improvement of shared R&D compute infrastructure.  You will work closely with a Senior Engineer to monitor, develop, deploy, and update physical and virtualized servers using DevOps tools.  As part of Research and Development, your work will affect every part of drug design, from basic microbiome research to clinical data analysis.  You will be part of a great team that emphasizes collaboration and learning new skills.

 

Your initial responsibilities will include:

  • Performing backup, file replication, and script management for servers
  • Planning, coordinating, and managing installation and maintenance activities of complex systems
  • Collaborating with DevOps colleagues to improve processes or resolve complex technical problems
  • Working with R&D colleagues directly to troubleshoot platform or connectivity issues
  • Analyzing networks and data centers, recommending improvements and technology upgrades
  • Enhance infrastructure and reconfigure software/hardware
  • Configuration, installation, and deployment of new infrastructure
  • Performing operational support tasks as required to maintain infrastructure uptime
  • Owning problem resolution, facilitating discussions, and providing status updates

 

We seek candidates with these qualifications:

  • Technical aptitude with an attention to details and a curious mind
  • BS degree in CS, Engineering, or a related technical discipline
  • Must be able to lift (up to 50 lbs.) and install server equipment using provided tools.
  • 3+ years of experience supporting end-user systems including datacenter operations
  • Strong background in Linux Administration and data center operations with a working knowledge of scripting: Unix shell, Perl, Python, and/or Ansible
  • Good knowledge of storage platforms and file systems (XFS, ZFS, Spectrum Scale)
  • Good understanding of network protocols, experience with InfiniBand a plus
  • Experience with monitoring and logging tools
  • Experience with the Atlassian toolkit
  • AWS and/or containerization experience a plus
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Job Summary

Seres Therapeutics is seeking a Validation Engineer to join our dynamic team. Our group is focused on supporting the manufacture of therapeutics for the microbiome by ensuring appropriate implementation of new and existing GMP procedures and facility assets and working to set and meet site manufacturing objectives. This individual is responsible for performing validation projects in a GMP biotech manufacturing facility.  S/He will also work closely with the Engineering and Facilities team in the development of the Validation Program.  The job requires an individual who can solve highly technical problems of diverse scope, interact with internal and external industry professionals, and consistently demonstrate critical thinking skills. S/He will report directly to the Sr Engineer, Validation.

Job Responsibilities

  • Authors, executes, and summarizes validation protocols for equipment/test instruments, critical utilities.
  • Performs hands on testing to new equipment and following modifications to existing equipment to ensure validation/qualification status is maintained in a state of control.
  • Develops and revises new or existing procedures.
  • Participate in equipment failure investigations and corrective/preventive actions.
  • Provide technical assessments on change controls, deviations, and investigations.
  • Contribute to the successful completion of project milestones and crucial technical tasks.
  • Act as a technical contact on projects requiring validation.

Required Skills and Qualifications

  • BS degree in engineering/life sciences or equivalent validation experience. 2-5 years of validation experience in biopharmaceutical, medical device, or FDA regulated environments.
  • Working knowledge of cGMP, GLP, and FDA regulations related to equipment and utility validations. Knowledge of typical pharmaceutical equipment and critical processes.
  • Must have a working knowledge of the fundamentals of equipment and utility qualification (IQ/OQ/PQ).
  • Excellent written and verbal communications skills.
  • Working knowledge of change management and change control requirements.
  • Experience performing root cause analysis investigations for deviations and non-conformances having technical scope.
  • Experience working in a highly-regulated environment, particularly biopharmaceutical cGMP procedures.
  • Familiar with GMP processing equipment, both fixed and single use. 
  • Knowledge of global cGMP requirements and expectations as they pertain to validation.
  • Detail oriented, independently motivated, and possess strong problem-solving abilities.

 

Apply for the Validation Engineer position

Vice President, Marketing

The VP Marketing is responsible for leading development and execution of commercial strategy for the entire portfolio of products from Seres Therapeutics, the leading microbiome company.

 

One of the first commercial hires for the company, this individual’s primary focus will be on preparing for the successful US launch of our SER-109 oral capsule in recurrent C. difficile infection while ensuring pipeline strategies and development plans are optimized to support successful commercialization. 

 

Reporting directly to the Chief Commercial and Strategy Officer, this key leader will have the opportunity to design and build a world class organization to support commercialization for all Seres products.  Remit includes but may not be limited to:  providing leadership and direction of all marketing and commercial strategies; ensuring strong strategic plans are developed and executed to support appropriate adoption of Seres’ novel therapeutics; developing cross-functional launch plans; partner with program teams in assessment of data generation and label expansion plans in support of enhancing commercial value; identification of innovative go-to-market models; determination of optimal size and structure of commercial organization including sales force and commercial operations team (e.g. business insights and analytics). 

 

As a member of the commercial leadership team, this position will work across the organization to ensure external stakeholder perspectives are reflected in key deliverables and decisions supporting commercial launch plans and clinical development.  

 

Seres Therapeutics, Inc., (Nasdaq: MCRB) is a leading microbiome therapeutics platform company developing a novel class of multifunctional bacterial consortia that are designed to functionally interact with host cells and tissues to treat disease. Seres’ SER-109 program achieved the first-ever positive pivotal clinical results for a targeted microbiome drug candidate and has obtained Breakthrough Therapy and Orphan Drug designations from the FDA. The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic. Seres’ SER-287 program has obtained Fast Track and Orphan Drug designations from the FDA and is being evaluated in a Phase 2b study in patients with active mild-to-moderate ulcerative colitis. Seres is developing SER-401 in a Phase 1b study in patients with metastatic melanoma, SER-301 for ulcerative colitis and SER-155 to prevent mortality due to gastrointestinal infections, bacteremia and graft versus host disease.

Seres Therapeutics is a member of the Flagship Pioneering family of companies, affording this individual broad exposure and access to other industry leaders in the Flagship fold. 

 

Seres is based in Cambridge, MA.  We recognize the complexities introduced by COVID-19 on travel, necessity for office-based work, and increased value of remote working.  This position will require a mix of Seres corporate office and external stakeholder interfaces therefore we are affording the right candidate flexibility with respect to their East Coast location.  Post-COVID travel will be required to support these critical interfaces. 

 

Responsibilities:

    • Lead commercial teams in developing go to market strategy and launch plans (positioning, messaging, distribution, pricing, launch sequence, etc.)
    • Design and build optimal sales and marketing organization to support the launch of SER-109 
    • As different teams are onboarded, ensure activities and resource planning of the Market Access, Market Research, Patient Advocacy, Sales, Marketing, and Medical Affairs groups are in alignment with commercial strategy
    • Build strong relationships with KOLs, patient advocacy groups, and key customers to establish mutually beneficial partnerships that advance standard of patient care and understanding of the role of microbiome therapeutics in key diseases of interest
    • Create revenue and unit forecasts for pipeline products to provide an assessment of asset value to product development teams and to support the portfolio planning initiatives including production forecasts
  • Ensure development of market and opportunity assessments and target product profiles to establish roadmap for pipeline product development; ensure optimized LCM plans are developed to maximize value of each Seres asset
  • Infuse commercial perspective to internal portfolio strategic reviews, making well-supported recommendations to maximize portfolio value  
  • Point of liaison for current and potential future external partners (e.g. with ex-North American partner Nestle Health Sciences for SER-109 and SER-287) to integrate commercial strategy, where appropriate for partnered assets
  • Attract, develop, and retain staff members; Inspire and elevate capabilities of others

 

  • Provide prompt and objective feedback and coaching to enhance or improve performance by setting expectations and holding individuals accountable for performance and behavior
  • Ensure compliance with corporate policies and procedures, as well as US healthcare laws and regulations

 

 

Qualifications:

  • Minimum of a bachelor’s degree; advanced degree preferred
  • 15+ years of broad and progressive experience within commercial roles ideally spanning marketing, new product planning, access, and sales
  • Recent experience running US P&Ls and recent US product launch experience
  • Demonstrated leadership ability and track record; building high-performing commercial teams; strong talent assessment capability and the ability to attract, retain and effectively coach top industry talent to superior performance. Strong ability to effectively engage and motivate people and lead change
  • Superb strategist / visionary who can originate competitive and creative strategies.  Independent thinker with analytical savvy. Ability to quickly manipulate numbers, draw conclusions and exhibit solid problem solving. High level of financial business acumen
  • Prior experience with strategic alliances (establishing and managing strategic relationships such as joint ventures, co-marketing agreements and development partnerships) a plus
  • This hire will be in a role of significant visibility within and outside the company and will possess superb communications skills, the comportment of a professional and the skill of a diplomat.  Strong customer orientation
  • Resourceful, flexible, adaptable, diplomatic, and able to effectively deal with ambiguity
  • Possesses a good blend of strategic and operational experience with the ability to see the big picture and strong attention to detail
  • Fit with Seres culture and values, especially encouraging candidates with diverse backgrounds and those who are inclined to listen as much as they are to decide/lead.    Seres is a highly collaborative environment and, therefore, consensus building will be a critical skill to ensure success in this role
     
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Our latest
news

Recurrent C. diff study now enrolling
An open-label study of SER-109

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Seres announces positive topline results for SER-109
SER-109 met primary endpoint in Phase 3 study in C. difficile

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