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

Role: Principal Scientist (Director level) leading downstream process development for late-stage and commercial biologics within the BDSC team, focusing on complex modalities like multi-specific antibodies. Responsibilities: oversee downstream and integrated drug substance teams supporting clinical and commercial programs, provide technical leadership in process characterization, validation, and tech transfers; collaborate across Manufacturing, Quality, and Regulatory functions; author regulatory documentation; support lifecycle management and process improvements; mentor scientific staff and shape downstream strategies. Requirements: BS, MS, or PhD in Chemical Engineering, Biological Engineering, Chemistry, or related; 6+ to 14+ years industry experience supporting biologics commercialization, with deep expertise in downstream processing including chromatography, filtration, and viral clearance; proven ability to lead cross-functional teams, execute complex projects, and support late-stage development and regulatory filings. Preferred: hands-on experience with biologics process validation, complex antibody therapeutics, and regulatory submissions; knowledge of GMP, analytical characterization, and operational excellence. High-Value: biologics, biologics downstream processing, late-stage clinical to commercial phases, multi-specific antibody platforms, process validation, regulatory authoring. Work setup: based in a hybrid or onsite environment with 10% travel.