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 Validation Supervisor you will be responsible for leading and/or supporting validation projects in a GMP biotech manufacturing facility. S/He will also support the development and success of the site validation programs and any ancillary remediation activities. 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.

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What You'll Do

• 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.

What You'll Bring

• Experience writing and executing Facility, Utility, and Equipment qualification documents
• Working knowledge of cGMP GLP, and FDA regulations related to life sciences
• Knowledge of typical pharmaceutical equipment and critical processes.
• 5+ years of validation experience in biopharmaceutical, medical device, or FDA regulated environments.

What You'll Also Bring

• Experience working within a commercial manufacturing facility
• A positive attitude
• A creative approach to solving problems
• The ability to embrace change enthusiastically
• A passion for this industry and bringing lifesaving therapies to patients

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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