Associate Director, Commercial Manufacturing & Packaging

Role: Associate Director of Commercial Manufacturing overseeing the strategy, planning, and execution of drug product manufacturing and packaging at external CMOs for a biopharma company focused on rare diseases. Objectives include ensuring reliable, compliant supply, managing manufacturing schedules, process validation, and risk mitigation. Responsibilities encompass coordinating manufacturing operations, selecting and qualifying CMOs, supporting troubleshooting, and contributing to regulatory submissions and audits. Qualifications: Bachelor's degree in Process/Chemical Engineering, Life Sciences, or related field; 8+ years of progressive pharmaceutical manufacturing experience, including process troubleshooting and optimization; experience with multiple dosage forms, especially oral solids. Preferred: deep knowledge of GMPs, process validation, technology transfer, and project management skills. High-value specifics: experience with GMP compliance, technical due diligence, and manufacturing network strategy in the context of rare disease therapies, with some international travel (~10%). Collaboration involves cross-functional engagement with Supply Chain, Quality, Regulatory, and Commercial teams. Work setup: hybrid with a requirement for onsite presence in San Diego and face-to-face interactions.