Why Seres Therapeutics

Seres Therapeutics is a commercial-stage company developing novel microbiome therapeutics for serious diseases. Our lead program, VOWST™, obtained U.S. FDA approval in April 2023 as the first orally administered microbiota-based therapeutic to prevent recurrence of C. difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI and is being commercialized in collaboration with Nestlé Health Science. We are evaluating SER-155 in a Phase 1b study in patients receiving allogeneic hematopoietic stem cell transplantation to reduce incidences of gastrointestinal infections, bloodstream infections, and graft-versus-host disease as well as additional preclinical stage programs targeting Infection Protection in medically compromised patients. We are also conducting research to inform further development of microbiome therapeutics for ulcerative colitis.

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 Associate Director, Manufacturing Sciences and Technology (MSAT), Process Lifecycle Management (PLCM) you will play a key role in the Seres' MSAT organization in support of both commercial and clinical manufacturing in close partnership with Quality, Manufacturing Operations, and Regulatory. Working closely with peers, this role will be responsible for establishing industry-leading business processes and capabilities in support of GMP drug supply (including deviation management, change control, regulatory inspection readiness and support, data management, and process monitoring), process lifecycle management for clinical and commercial processes, and driving continuous improvement across products and platforms.

What You'll Do

• Lead and/or support complex process investigations and process changes, as a technical subject matter expert (SME).
• Act as technical SME for clinical and commercial tech transfers including optimization of tech transfer business tools.
• Support and help facilitate a cross-functional forum to develop multi-year process lifecycle management (PLCM) and continuous improvement strategies.
• Lead and/or support implementation of improvements to clinical and commercial processes, including optimization of process design and control strategy.
• Support development of process validation strategy to support new process introductions and/or changes to validated processes, including development of comparability plans.
• Support development of Continued Process Verification (CPV) analyses, plans, and reports.
• Facilitate process data review and statistical process control evaluations across manufacturing and testing sites. Serve as liaison with internal and external statistical experts.

What You'll Bring

• Bachelor's degree in science, engineering, or related field with approximately 6 to 8+ years of experience or Masters in degree with approximately 4 to 6+ years of experience in biopharma manufacturing or relevant industry
• Experience with quality systems management, including Deviations, CAPAs, and Change Controls.
• Root cause analysis and statistical process control training and experience.
• Experience with risk-based and phase-appropriate process design and control strategy development and process validation lifecycle.
• Strong analytical and structured problem-solving skills.
• Proficient computer skills utilizing MS Office suite applications and statistical analysis software.
• Strong interpersonal, verbal, written and presentation skills.
• Detail oriented, independently motivated and possess strong problem-solving abilities in collaborative environments.

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.

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