Associate Director, Technical Operations

Remote

Planet Pharma

Posted 3 days ago

San Diego · RemoteLast seen today

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Summary

Lead CMC (Chemistry, Manufacturing, and Controls) strategy and execution for a portfolio of small-molecule drugs in development through commercial launch. Oversee external manufacturing partners (CMOs), ensure technology transfer and scale-up activities meet regulatory and quality standards, and provide technical leadership across clinical phases I–III and commercialization. Author regulatory submissions, manage compliance with cGMP requirements, and mentor cross-functional teams. Requires 8+ years of progressive CMC/manufacturing experience with demonstrated leadership in drug development and process validation.

Technical Program Management Analytical Methods API Manufacturing Biologics Cgmp Change Controls Cmc Strategy Cmo Management Finished Dosage Forms Injectables Manufacturing Controls Master Batch Records Oral Solid Dosage Forms Peptides Phase I Clinical Phase Ii Clinical Phase Iii Clinical Process Validation Regulatory Compliance Regulatory Submissions Scale Up Technology Transfer