Associate Director/Director - Upstream Process Development
Greater Boston Area
Competitive Compensation + excellent bonus/benefits
Duties and Responsibilities:
- Lead upstream process development(Late-Stage) and cell line development/banking activities for Biologics Portfolio (mAb & proteins)
- Lead outsourced upstream processes to domestic & international vendors
- Set strategy for process development, optimization, validation, GMP manufacturing, and regulatory filings
- Support R&D, commercial, manufacturing, quality assurance and business development departments
Qualifications:
- Experience working cross functionally with senior leadership (QC, Analytical, Manufacturing, Regulatory, Business Development, etc. )
- Past experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs) and internal R&D activities
- Past experience having late stage process development studies.
- M.S or Ph.D. in Pharmaceutical Sciences or a related scientific field with ideally 5-8 years of industry experience
