Summary:
We are recruiting for a Senior Scientist, Upstream Process Development to join an exciting clinical-stage company focused on novel vaccines. This position will join the technical development group within the process development team to lead drug substance process development and manufacturing.
Responsibilities:
- Oversee the development of upstream process development activities (fermentation, microbial strain, cell culture, etc.)
- Work in house and in collaboration with CDMOs
- Implement new and advanced technologies for improvement of microbial platforms
- Lead scale up, process optimization, tech transfer, and validation of upstream processes
- SME for upstream drug substance activities for IND filings and clinical development
- Author and review sections for CMC regulatory submissions & technical reports
Qualifications:
- Advanced degree in a related field (Ph.D. with 5 years of experience OR M.S. with 8 years of experience in industry)
- Experience with vaccines or recombinant proteins is highly desirable
- Experience working with CDMOs and external vendors
- 5 years of experience developing upstream processes from microbially expressed recombinant proteins
Benefits:
- This role is hybrid in Boston (3-4 days per week onsite).
- Unlimited PTO
- Employee Stock Plan
- Annual Bonus
