Director, Drug Product Development

The ideal candidate will take on the following tasks:

Act as the subject matter expert in PFS process development and manufacturing.
Drive late-phase and commercial launch strategy for PFS development and manufacturing.
Lead drug product tech transfer, process development, and GMP manufacturing operations, including person-in-plant support.
Oversee CDMO performance, ensuring adherence to deliverables and timelines.
Apply QbD principles to conduct risk assessments and shape phase-appropriate manufacturing strategies across process transfer, scale-up, PPQ, and commercial readiness.
Partner with drug product and device teams to advance presentations across vials, PFS, autoinjectors, and emerging delivery technologies.
Work cross-functionally with Quality and external partners on batch record review, deviation resolution, and regulatory filings including INDs, IMPDs, and BLAs.

The ideal candidate will possess the following qualifications:

10+ years of industry experience in drug product development and manufacturing.
5+ years in clinical and/or commercial GMP operations for PFS drug products.
Proven leadership in GMP manufacturing of combination products.
Deep expertise in biologics process development and aseptic manufacturing, preferably mAbs.
Track record managing CDMO relationships including tech transfers and GMP oversight.
Experience with PPQ, biologics commercialization, and PAI readiness.
Extractables/leachables risk assessment experience preferred.