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
• 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.