Associate Director, External Drug Product Manufacturing

About the role

This position of Associate Director, External Drug Product Manufacturing will oversee on-going and new drug product aseptic filling demands at Contract Manufacturing Organizations (CMO’s) and budget management while adhering to Good Manufacturing Practices, company policies and procedures. This individual shall support the Contract Manufacturing Organization providing oversight of aseptic drug product manufacturing.

Responsibilities

• Provide oversight as person-in-plant (PIP) for Drug Product fills at CMOs.
• Lead CMO’s by providing forecasts, requesting quotations for drug product manufacturing operations.
• Liaise with the clinical teams and commercial teams to create product forecasts.
• Investigate and onboard new Drug Product Manufacturing CMO’s.
• Review and approve invoices.
• Review master and executed batch records.
• Review excursions or deviations that may occur during shipment, handling, and storage of drug products.
• Drive such investigations to resolution in collaboration with Quality, CDMO and clinical