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

Role: Principal Scientist (Director level) leading downstream purification for late-stage and commercial biologics programs, including complex modalities like multi-specific antibodies. Objectives: support process development, validation, characterization, and technology transfer to enable manufacturing and regulatory success. Responsibilities: oversee downstream teams, provide technical leadership in process scale-up and validation, author regulatory documentation, and collaborate across Manufacturing, Quality, and external partners. Manage investigations, lifecycle activities, and strategic initiatives to advance biologics manufacturing. Qualifications: PhD or MS in Chemical or Biological Engineering, Chemistry, with 6+ (PhD), 12+ (MS), or 14+ (BS) years of biopharma industry experience supporting biologics commercialization, with deep expertise in downstream processing including chromatography, filtration, and validation. Preferred: experience with multi-specific antibody formats, late-stage process characterization, regulatory submissions, and technology transfer. Skills: process development, scale-up, regulatory writing, cross-functional leadership, and operational excellence. High-Value: biologics (antibodies, multi-specifics), late-stage development, process validation, manufacturing transfer, and regulatory support for global commercial programs. Collaboration: cross-divisional, external CRO/CMO partners. Work setup: hybrid, with 10% travel.