Semma Therapeutics, a biotechnology company focused on developing a stem cell-based cell therapies, is seeking an outstanding Director of Clinical Materials Production (GMP Manufacturing) to join its growing team. The full-time role will be responsible for the technology transfer and production of cell therapy products to support Semma’s Phase I/II clinical trials. Clinical Materials produced in the facility will be manufactured according to Good Manufacturing Practices (GMP) and conducted under Investigational New Drug (IND) applications with the US Food and Drug Administration (FDA). The Director will ensure production methodologies and products are suitable for their intended use and consistent with all regulatory requirements for investigational use in humans. The position will be located in Cambridge, MA (Kendall Square).
- Co-ordinates and facilitates technology transfer and final process development from the Research to the Manufacturing group
- Oversees the development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with Research and Quality Systems groups
- Ensures raw materials are identified and available and human resources are trained and scheduled for required clinical materials production activities
- Oversees daily clinical materials production activities and reviews and approves production batch records
- Liaises with Quality Systems and Operations groups to ensure proper coordination of resources
- Ensures cGMP compliance through manufacturing oversight and tracking
- Provides regular GMP production status updates
- Supports regulatory filings and inspections as required
- Serve as a liaison to senior management, cross-functional areas and external organizations such as sponsors and government agencies
- Hires, trains, supervises, reviews and mentors Manufacturing staff
- Other duties and projects as assigned
- Bachelor’s degree in Biological, Bioengineering, Chemical Engineering or process related sciences required. Advanced degree preferred.
- Extensive (>15 years) cell culture experience required. Experience with iPSC cells and their derivatives preferred.
- At least 10 years prior GMP manufacturing experience required. At least 5 years working in process development and/or manufacturing of cell therapy products preferred
- Expertise in cell processing and culture technologies for clinical materials production required. Experience with 3 to 15-liter scale perfusion bioreactors for cell culture preferred.
- Strong knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820) required
Please note that applicants should have authorization to work in the United States. Semma offers competitive pay, health insurance, time-off among other benefits. Please, fill out the form below and include your resume.