Associate Director, Technical Operations

$150,000 – $195,000 · Posted 3 days ago

San DiegoLast seen 1 day ago

Summary

Associate Director of Technical Operations at a biopharmaceutical company overseeing CMC (Chemistry, Manufacturing, and Controls) strategy for a diverse portfolio of small-molecule drugs in development through commercialization. Leads external manufacturing partners (CMOs), manages technology transfer and scale-up activities, ensures cGMP compliance, and authors regulatory submissions. Requires 8+ years of progressive CMC and drug development experience with demonstrated leadership across multiple CMC disciplines and small-molecule, peptide, and biologic manufacturing.

Technical Program Management Analytical Methods API Development Batch Record Review Biologics Cgmp Change Control Cmc Chemistry Manufacturing And Controls Cmo Qualification Finished Dosage Forms Injectable Formulations Manufacturing Controls Oral Solid Dosage Forms Peptides Process Validation Regulatory Submissions Small Molecules Technology Transfer Vendor Management