Sr. Director - Process Sciences (Biologics)
Greater Boston Area | East Coast | Remote
Competitive Compensation + excellent bonus/benefits
Duties and Responsibilities:
- Lead upstream process development, downstream operations, and process engineering
- Oversee internal (remote manufacturing), domestic & international vendors
- Lead numerous state-of-the-art R&D programs from discovery, early-stage development, late-stage development, process validation, CMC Prep, Commercialization, and Launch
- Support R&D/CMC, commercial, manufacturing, quality assurance and business development departments
Qualifications:
- Experience working cross functionally with senior leadership (QC, Analytical, Manufacturing, Regulatory, Business Development, etc. )
- Experience overseeing outsourced vendors (CDMOs) and internal R&D activities
- Expert authoring and strategically working on IND/IMPD - BLA/MAA submissions
- M.S or Ph.D. in Pharmaceutical Sciences or a related scientific field w/ ideally 10 or more years of industry experience