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Job description
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
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.
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Worksite address
california, MO, 65018, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.