Senior Scientist, Purification Process Development

Role: Lead downstream process development scientist focusing on early phase purification operations for biologics, ensuring GMP scalability and transfer. Responsibilities: develop and optimize purification processes, establish CQAs, perform risk analyses, author technical and regulatory documentation (IND, IMPD, BLA), oversee process characterization, and collaborate with external CDMOs for scale-up and tech transfer. Provides technical oversight of GMP manufacturing and manages batch documentation for release. Requirements: PhD, MSc, or BSc in Chemical/Biochemical Engineering or related fields, with 8+ years (5+ for PhD) industry experience in downstream process development for biologics, including GMP manufacturing. Must have expertise in process scale-up, characterization, and regulatory compliance, with experience working with contract manufacturing organizations. Preferred: knowledge of QbD, DoE, cGMP, and regulatory guidelines (ICH). High-Value: biologics, therapeutic areas such as cancer, autoimmune, or inflammation, early stage development (preclinical to Phase 1/2), GMP process development, and regulatory documentation. Work setup: hybrid in Bellevue, WA, with a minimum of 3 days onsite.