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Director/Principal Scientist, Biologics Drug Substance Commercialization (BDSC)

Merck
September 02, 2026
Full-time
Remote friendly (West Point, PA)
Worldwide
Operations
Role: Principal Scientist/Director in Biologics Drug Substance Commercialization, focused on late-stage and commercial upstream biologics processes. Responsibilities: lead process development, technology transfer, validation, and lifecycle management for biologics, including complex antibody therapeutics; provide technical leadership across upstream operations, collaborate with cross-functional teams, and support regulatory documentation. Requirements: PhD/MS/BS in Chemical, Biological, or Biochemical Engineering with 8+ to 16+ years of industry experience; deep expertise in cell culture process development, biologics commercialization, and GMP manufacturing. HighValue: biologics, upstream processing, late-stage and commercial programs, antibody therapeutics, process validation, regulatory submissions, cross-functional collaboration, leadership in process characterization and scale-up. WorkSetup: likely hybrid or onsite with ~10% travel.