Manager, Biologics Drug Substance External Manufacturing

Role: Manager of Biologics Drug Substance External Manufacturing overseeing GMP external production for clinical and commercial biologics. Responsibilities: monitor manufacturing batches at CDMO sites, review batch records and reports, support process validation and continuous process verification, facilitate technology transfer of pipeline candidates, and collaborate with analytical, quality, and regulatory teams for batch release and investigations. Qualifications: Bachelor's in Life Sciences, Pharmacy, Chemistry, or related; 4+ years in biotech/pharma manufacturing; 2+ years experience with biologics CDMOs and late-phase biologics programs. HighValue: biologics drug substance, GMP manufacturing, process validation, CPV, late-phase programs, cross-functional collaboration. WorkSetup: on-site at CDMO; travel about 30%.