Associate Director, Technical Operations, Biologics Drug Substance Manufacturing

Role: Associate Director, Technical Operations (Biologics Drug Substance Manufacturing), overseeing late-stage clinical and commercial biologics manufacturing, primarily focusing on downstream microbial fermentation processes. Responsibilities: provide technical oversight for manufacturing at CDMOs, review and approve process and validation documentation, support process transfer, scale-up, and lifecycle activities, monitor process performance, and prepare technical regulatory submissions (IND/BLA). Qualifications: Bachelor’s in Life Sciences, Chemistry, or related field with 8+ years in biologics manufacturing, especially supporting late-stage development and commercialization. Preferred: advanced degree (MS/PhD), experience with PEGylation, QbD, process validation, and regulatory submissions. Relevant biopharma specifics include expertise in microbial fermentation, downstream processing, process optimization, and working within cGMP frameworks. Experience with external CDMOs, process characterization, statistical process monitoring, and troubleshooting is essential. The role requires strong technical writing, cross-functional collaboration, and 20-25% travel. Work setup: primarily remote with onsite requirements in San Diego.