Director, Pharm Operations
Direct all CTM supply activities including collaboration with Clinical Operations to forecast drug product, comparator and budget requirements, planning, kit & label specifications, IVRS/IWRS/IRT & distribution logistics.
Identify, evaluate and ensure outsourced vendors have the required expertise, capabilities, and quality/compliance standards to support drug product manufacturing and packaging.
Direct the budgeting, contracting, scheduling, manufacturing, packaging & testing of drug products at CMO sites.
Assemble and maintain a Pharmaceutical Development information repository to allow efficient retrieval of manufacturing and packaging records as well as API, bulk drug product and CTM inventory.
Represent Pharmaceutical Operations in Company-CMO project team meetings and inform both up and down the chain of command as to progress, resource requirements and timelines.
Provide full operational support services to the Analytical, Formulation, Manufacturing and Clinical Supply functions.
BA/BS/MS in Chemical or Pharmaceutical Sciences
15+ years of industry experience developing, implementing & manufacturing GMP pharmaceutical drug products for clinical trial use including oral solid dosage forms and parenteral dosage forms