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SalaryWhy 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. Seres has multiple clinical products moving through the development pipeline and one marketed product that have active stability programs which you will oversee. In addition, you will be playing a key role in managing a team and lab that performs key methods on starting raw materials (SRM)to move products forward to patients. Additionally, your technical experience will be applied to challenging problems associated with technical support of quality control operations including specification creation and updates, eQMS workflow management, change control and continuous improvement.
What You'll Do
- In collaboration with the Associate Director/Director of QC operations, oversee Seres Therapeutics laboratory operations at 200 Sidney Street, Cambridge, MA and 9 Fourth Avenue, Waltham, MA
- Oversee Clinical and Commercial analytical testing, documentation, data review, reporting and archival.
- Perform Certificate of Testing (CoT) and Lot Release Protocol (LRP) authoring or review
- Oversee and, as necessary, perform various QC functions including but not limited to: Environmental Monitoring/Utility Monitoring (EM/UM) program oversight, technical document authoring and review, SOP generation and maintenance, eQMS ownership and delegation for QC-related change controls, exceptions, CAPAs and CIs
- Maintain cGMP systems in an audit-ready state, particularly the stability program and related reports.
- Support internal QA and safety audits and external regulatory and partner audits.
- Present data and performance metrics within scope internally and externally as appropriate
- Recommend and implement process and system improvements as warranted.
- Develop staff: expand breadth and depth of your team members' capability to deliver on department expectations and facilitate retention and career progression including succession planning.
- Maintain a system of department communication flow, attend internal and extra-QC forums such as tier meetings, IST and EST as necessary.
What You'll Bring
- BS/BA degree in biology, biological engineering, chemistry, or a similar field with 6+ years of related experience in GMP testing operations.
- Experience with operations and people management under ICH and/or FDA guidelines.
- Experience executing microbiological assays (i.e. bioburden, microscopy, microbiological identification) and molecular assays (qPCR, PCR etc.).
- Experience with JMP, Minitab, R or similar software.
- Must be detail-oriented, enthusiastic, proactive, collaborative and organized.
You May Also Bring
- Some non-routine travel may be required.
- Flexibility with scheduling requirements-may include shifts, overtime, weekends, and holiday coverage, including during adverse weather conditions.
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.
