Associate Director, Technical Operations, Biologics Drug Substance Manufacturing

Role: Associate Director, Technical Operations for Biologics Drug Substance Manufacturing, overseeing late-stage clinical and commercial biologic manufacturing with a focus on downstream processes. Responsibilities include providing technical oversight at CDMOs, reviewing manufacturing documentation, supporting process validation, tech transfer, lifecycle management, and regulatory documentation for BLA submissions. Collaborates with Quality and Regulatory teams; monitors process performance for optimization. Qualifications: Bachelor's in Life Sciences or related; 8+ years in biologics manufacturing, scale-up, and late-stage development. Preferred: advanced degree, expertise in microbial fermentation, downstream processing, process validation, and regulatory submissions (BLA, IND). High-value: biologics (recombinant proteins), late-stage clinical to commercial phases, process validation, QbD, GMP compliance, external CDMO oversight, 20-25% travel. Work setup: hybrid remote in San Diego with face-to-face requirements.