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

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.

Manager, Stability:

We are seeking a highly motivated Stability professional for Seres manufacturing pipeline products. The individual will be responsible for improvement, development, implementation and maintenance of the stability programs and internal procedures and processes in compliance with regulatory requirements and commitments for clinical products.  The individual will work closely within the QC organization and external laboratories to ensure testing completion and will review and trend the stability results.

Key Responsibilities:

  • Maintain stability programs in compliance with regulatory requirements and commitments for clinical products.
  • Author and/or revise internal procedures and develop and implement processes as part of continuous process improvements related to the stability program
  • Author or amend stability protocols, and author interim and final stability reports.
  • Maintain documentation associated with the conduct of a stability study, in accordance with internal procedures and aligned with ICH guidance.
  • Review stability results real-time; report suspect out-of-specification results in timely manner to ensure appropriate immediate actions are taken.
  • Perform periodic review and analysis of stability results for comparability studies, shelf life, degradation rates, trending and trend limits.
  • Ensure stability chambers have been appropriately validated, calibrated and maintained.
  • Manage and monitor stability inventory, milestones and detailed timelines for stability studies while providing transparent communication. These responsibilities may include overseeing stability activities at external laboratories, as applicable.
  • Coordinate the stability testing schedule and maintaining relationships with external laboratories to ensure timely completion and reporting of results for a stability time point.
  • Oversee inspections and inventory of stability samples annually for each study.
  • May author, or supervise staff in the writing of, stability related quality system records, including their investigations.

Qualifications:

  • BA/BS or MS degree in Chemistry, Biochemistry, Microbiology, Biology or other related field with 5+ years of GMP experience within Stability
  • 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
  • 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 QC stability programs for biologics drug substance and injectable drug product in a commercial environment
  • Experience with statistical analysis tools, e.g., SAS JMP
  • Experience with preparing regulatory documentation
Apply

Your Mission

As part of the Quality Systems shared services group this role will provide quality oversight and expertise for the qualification, verification, and validation of GxP equipment systems and processes. Working with R&D, Clinical, Development and/or Manufacturing functional leads, this role will ensure activities involving the commissioning, qualification, verification and/or validation of systems and processes are performed via Seres internal controls and meet regulatory requirements.

What You’ll Do

  • QA oversight of the Seres Validation Program efforts including GxP test methods, facilities, utilities, equipment, process, and computerized systems.
  • Assist business partners with the development of validation plans and protocols
  • Work with QA partners to ensure execution was performed
  • Identify key areas of improvement supporting GxP validation efforts
  • Support business partners in making sure that the defined methodology and approach for supporting qualification validation initiatives are performed with scientific, regulatory compliance and statistical validity (as applicable)
  • Support projects teams as the Quality SME for review/approval of deliverables associated with equipment systems and processes. This includes the tech transfer, qualification, verification, validation and reverification activities
  • Provide training to business partners to educate as needed to support validation, qualification and verification activities
  • Ensure that there is adequate rationale defined for the closure of generated non-conformances, discrepancies and deviations associated with verification/validation execution efforts.
  • Assist and support QA Operations in the evaluation of risk assessments related to validated state of equipment and processes.
  • Necessary review and approval of QA change management activities and reviews on changes to verification/ qualification and requalification applicable GxP procedures.
  • General QA support for all functions and as needed for outside vendors for CMC, Donor Operations and Clinical Operations.

 

What You’ll Bring

  • Bachelor’s degree in life sciences, or engineering with 8 to 10 years of experience in the biotech/or pharmaceutical industries
  • Experience supporting equipment, instrument and system qualification activities in R&D, Clinical or Manufacturing commercial organizations.
  • Experience in supporting cleaning and process validation campaigns
  • Experience supporting Test Method Verification/Validation activities (preferred)
  • Support change controls, deviations, investigations root cause analysis and CAPAs as required
  • Demonstrate strong organizational and interpersonal skills, building relationships with effective communication, influencing, conflict resolution, critical thinking and problem solving with a keen attention to detail.
  • Advanced knowledge and demonstrated experience using Industry International Standards and Guides (USP/ EP/ ISO/ IEEE/ ASTM/ ISPE/ PDA) and applicable GXP FDA, Canada, European, ICH regulations & guidelines
Apply

The Senior Clinical Trial Associate will work with the Director and VP Clinical Operations to support the conduct of clinical trials. The CTA may provide support for various clinical trials and may manage certain aspects of the clinical trials. The CTA will partner with the Clinical Project Managers to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.

  • Work with Clinical Operations to oversee the CROs, as appropriate, to ensure the successful conduct of clinical trials
  • Assist with the development and maintenance of tracking tools for patient recruitment, site ramp-up, monitoring visits and site payments
  • Maintain the Trial Master Files (TMF) in house and ensure all documents are up to date. Oversee the external TMF vendor.
  • Support Director and VP of Clinical Operations with activities outlined in the Clinical Oversight Plan
  • Responsible for the drafting of minutes and action lists for the Clinical Trial Execution and Clinical Operations Meetings
  • Review monitoring visit reports to ensure proper conduct and oversight as needed
  • Develop and assemble study-related tools, guides, and documents as needed
  • Work with Clinical Supply group to track study drug expiration dates and ensure sites have adequate supply based on protocol requirements
  • Works with Clinical Operations colleagues to ensure study staff is appropriately trained on relevant guidelines, regulations and SOPs

Responsible for

  • Facilitate the receiving, processing and tracking of Investigational Product shipments across all trials
  • Manages the external distribution lists for Investigator Brochures
  • Assist with the creation of Power Point presentation templates for various publications
  • Assist in the planning of various meetings and events for the Clinical Operations group
  • Reconcile invoices to their corresponding contracts and budget, and assist with investigator site payments
  • Prepares and manages study communications including newsletters and study updates
  • Assists with the collection, tracking, and review of regulatory documents
  • Responsible for communication and escalation of study related risks and issues as required
  • May represent Clinical Operations in cross-functional initiatives

Requirements

  • Bachelors; RN or BSN preferred
  • Three or more years’ experience in clinical operations- experience with Sponsor setting desired.
  • Knowledge of FDA regulatory requirements and ICH/GCP guidelines essential
  • Demonstrated efficiency in partnering with CROs and vendors
  • Computer proficiency (Word, Excel, PowerPoint, Project)
  • Works proactively and efficiently in a fast-paced, high change environment
  • Excellent written and oral communication skills
  • Outstanding organization skills
Apply

Why Seres Therapeutics

At Seres Therapeutics, we have a singular mission to transform the lives of patients by targeting the underlying cause of their diseases. We are pioneers and explorers, charting a new course. You’ll have the opportunity to truly define your area of focus.

If you have a pioneering spirit, join us as we ignite a revolution in the treatment of disease through the microbiome.

What’s Your Mission?

Seres needs a Clinical Trial Manager (CTM), who will report in to the Senior Director of Clinical Operations. The mission of this role is to drive the execution of a new clinical program. As such, the role directly impacts Seres’ ultimate goal of developing novel microbiome therapies to patients in need.

This CTM will need to independently organize and manage multiple clinical trial activities including facilitating cross-functional team meetings, managing vendors, and addressing protocol related questions. S/he would also be ensuring that study milestones are met and that the trial is completed in accordance with the protocol, study milestones and within budget.

What You’ll Do.

  • Responsible for all operational management of clinical trials. Position serves as lead for a new clinical program
  • Selection and management of CRO, vendors and consultants that are involved with the clinical trial
  • Oversee vendor(s) to ensure compliance with contract specifications (including budget), SOPs and the study Oversight Plan, including review of CRO progress reports and metrics
  • Coordinate financial and legal documentation exchange between sponsor, vendors and sites
  • Establish/maintain study milestones and ensure accurate tracking and reporting of study metrics and timelines
  • Organize and facilitate/document study cross-functional team meetings
  • Serve as point person for trial execution internally & externally
  • Coordinate and participate in data reviews in conjunction with Data Management staff
  • Review study Trial Master File periodically for quality control measures Review and provide input for clinical study documents such as informed consent, protocols, Investigator’s Brochure, recruitment materials, yearly updates to the regulatory authorities and status updates
  • Review and approve study related plans generated by CRO and study vendors
  • Responsible for oversight of identification and selection of investigator sites
  • Responsible for communication and escalation of study related risks and issues as required
  • Ensure study staff is appropriately trained on relevant guidelines, regulations and SOPs
  • Assist in the oversight of monitoring activities and site visits
  • May represent Clinical Operations in cross-functional initiatives
  • Participate in review and revision of departmental SOPs, provide support to establish and maintain operational infrastructure
  • Manage and attend Investigator Meetings, conferences, and perform co-monitoring as needed

What You’ll Bring.

  • Knowledge – thorough understanding of GCP/regulatory requirements
  • Proactiveness – the ability to identify challenges and risks and implement appropriate actions with some supervision
  • Motivation – highly motivated and self-starter; able to organize and perform complex tasks with minimal supervision
  • Strong communication – able to communicate clearly (in writing and verbally)
  • Collaboration – to coordinate activities of internal cross-functional study team as well as external vendors as applicable
  • Leadership – skills to lead and motivate a team for timely study execution
  • Open-mindedness – listen to ideas from others and seek guidance when applicable; inform manager as situations arise to brainstorm and seek best solutions

You May Also Bring.

  • Demonstrated computer skills including functional knowledge of Microsoft packages and ability to develop proficiency in technical systems and programs
  • Experience developing, reviewing, and approving study operational plans including site monitoring and risk mitigation strategies, trial budgets, site feasibility and clinical metrics tracking reports
  • Experience managing CROs, vendors, and/or clinical trial consultants

Preferred Education & Experience.

  • B.S. (or equivalent experience) and 3 – 6 years of relevant work experience
  • M.S. (or equivalent experience) and 2 – 4 years of relevant work experience

Who We Are.

Seres Therapeutics is a clinical stage biotherapeutic company focused on discovering and developing Ecobiotic™ therapeutic products, novel drugs to treat important diseases by targeting the underlying biology of the human microbiome. Founded by Flagship Pioneering, Seres is pioneering the first therapeutics that catalyze a shift to health by augmenting the biology of the microbiome. Current candidates span infectious, metabolic, and inflammatory diseases. For more information, please visit http://serestherapeutics.com/

Apply

Why Seres Therapeutics

At Seres Therapeutics, we have a singular mission to transform the lives of patients by targeting the underlying cause of their diseases. We are pioneers and explorers, charting a new course. You’ll have the opportunity to truly define your area of focus.

If you have a pioneering spirit, join us as we ignite a revolution in the treatment of disease through the microbiome.

What’s Your Mission?

As a Clinical Research Liaison, you will serve as a key liaison between Seres Clinical Operations group and the sites and site personnel (e.g. study coordinators, investigators) for Seres clinical trials to ensure optimal conduct and implementation of Seres trials with regards to enrollment and compliance with GCP and regulatory requirements.

What You’ll Do

  • Develop and maintain successful relationships with clinical investigators, clinical research organizations (CRO) and research institutions to initiate and expedite clinical studies on investigational new drugs
  • Develop and maintain successful relationships with study-center healthcare providers, including clinical trial investigators, study nurses/coordinators, data coordinators, and other study professionals to support patient recruitment activities
  • Work closely with sites and site personnel to develop study and/or site patient recruitment and retention tactics and strategies appropriate to the individual study needs, and generate and monitor enrollment modeling scenarios and continuously evaluate the recruitment projections for improvements or triggers to support the implementation of action and/or contingency planning
  • Work with CRO personnel (CRAs, CTMs, PM’s) to ensure proper study conduct, review trends and help develop mitigations for implementation
  • Responsible for oversight of monitoring activities performed by CRO to ensure compliance with monitoring plan for study(ies) and appropriate issue escalation
  • Monitor progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.
  • Contribute to development and review of clinical study documents
  • Assist with identification of potential clinical investigators
  • Ability to deliver presentations to clinical trial investigators and other health care personnel

What You’ll Bring

  • At least 5 years of previous experience as, monitoring/clinical research associate, clinical study coordinator or clinical project management experience of industry sponsored clinical trials
  • Applied understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.)
  • Additional experience should include demonstrated computer skills (MS Office, MS Project, PowerPoint), strong business communication skills (written; verbal; presentation), and initiative and ability to identify issues and create solutions
  • Ability to handle and prioritize multiple therapeutic areas and projects simultaneously
  • Experience working independently in a regional area with remote or minimal supervision
  • The successful candidate should have the ability to travel up to 50% to domestic locations

You May Also Bring

  • Prior experience guiding and mentoring clinical study staff, and patient recruitment and strategic patient recruitment planning experience is highly desirable
  • Competencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfaction
  • Experience with Regulatory and Quality Assurance audits

Who We Are

Seres Therapeutics is a clinical stage biotherapeutic company focused on discovering and developing Ecobiotic™ therapeutic products, novel drugs to treat important diseases by targeting the underlying biology of the human microbiome? Founded by Flagship Pioneering, Seres is pioneering the first therapeutics that catalyze a shift to health by augmenting the biology of the microbiome. Current candidates span infectious, metabolic, and inflammatory diseases. For more information, please visit http://serestherapeutics.com/

Apply