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Senior Manager, Biologics Manufacturing Technical Support

Celldex
September 04, 2026
Full-time
Remote friendly (Hampton, NJ)
Worldwide
Operations
Role: Senior Manager, Biologics Manufacturing Technical Support, oversees technology transfer, process validation, and manufacturing support for biologics. Responsibilities include leading scale-up activities, managing CDMO batch data analysis, investigating deviations and OOS/OOT issues, and serving as person-in-plant when needed. The role collaborates with cross-functional teams such as manufacturing sciences, quality, and analytical groups to ensure successful tech transfer, process validation, and continuous process verification. Qualifications: Bachelor's in Life Sciences, Engineering, or related field; 6+ years in biotech/pharma manufacturing; 3+ years working with biologics CDMOs; experience with late-phase biologics programs; strong data analysis skills; ability to travel 30%. HighValue: biologics manufacturing, process validation, CDMO oversight, late-phase biologics, GxP adherence, statistical data analysis tools (JMP/Minitab), cross-functional collaboration. WorkSetup: not specified.