Senior Manager of Upstream Process Development
Greater Boston Area
Company Summary: A leading Biotechnology company that is pioneering new drug development processes in the Life Sciences industry. Specifically, they have over 200 different development projects from cell therapy and viral vector production to vaccines.
Duties and Responsibilities:
- Lead late-stage upstream process development and cell line development/banking activities for Biologics Portfolio (mAb & proteins)
- Lead upstream processes outsourcing to domestic & global vendors.
- Set strategy for process development, optimization, validation, GMP manufacturing, and regulatory filings.
- Support R&D, manufacturing, commercial, business development and quality assurance departments
- M.S. or PhD in Pharmaceutical Sciences or related field with 3-7 years of experience in the industry.
- Experience working cross functionally with senior leadership (QC, Analytics, Manufacturing, Regulatory, Business Development, etc.)
- Experience overseeing outsourced vendors (CROs/CMOs/CDMOs/CTLs) and internal R&D activities
- Experience having late-stage process development studies.