Associate Director, Parenteral Drug Product Development & Manufacturing
Piper Companies is seeking an Associate Director, Drug Product Development & Manufacturing in Wilmington, DE to join a biopharmaceutical company focused on discovery and development of innovative molecule therapeutics targeting novel pathways for the treatment of cancer and rare diseases.
The AD oversees development and manufacture of formulations for molecule drug candidates to advance company portfolio programs through clinical trials and potential commercial launch. The individual forms close collaboration with functional leads, supply chain, and 's to establish fit for purpose development plans. The individual is responsible for managing CMOs and other external resources and is experienced in technologies related to drug product manufacture such as aseptic processing and lyophilization. This position reports to Director/Senior Director, Technical Operations.
Responsibilities and Duties:
• Works with contract development and manufacturing organizations ( or ) to develop and manufacture robust dosage forms for molecules providing end-to-end project oversight. Provides expert level virtual oversight for drug product development, scale-up/optimization, and manufacturing activities.
• Supervises activities at CDMOs and affiliates to ensure effective execution of manufacturing activities.
• Maintains oversight on product risk assessment, performance metrics, and controls: review/approval of manufacturing development reports or batch records, manufacturing change controls, deviations etc in close collaboration with Quality Assurance.
• Leads drug product manufacturing and validation activities for dosage forms for molecules. Thoroughly understands drug pre-formulation and stability concepts.
• Prepares and executes phase-appropriate drug product development project plans: prepares RFPs, evaluates bids, contributes to vendor selection.
• Works closely with Quality Assurance and Legal to ensure appropriate quality/service agreements, business processes, and performance metrics are in place for all 3rd party operations. Collaborates with QA for vendor audits (leads technical audits).
• Writes development reports, QbD documents, and contributes to the preparation of the drug product sections of regulatory documents (IND, IMPD, NDA).
• Partners with Quality Assurance in the development and implementation of quality processes for compliant conduct of technical operations.
• Performs internal and external quality audits in coordination with Quality/Regulatory/CMC functions to establish oversight on vendor operations.
• Represents technical operations in cross-functional teams and health authority meetings (e.g., EoP/CMC meetings)
• PhD./M.S. in Pharmaceutical Sciences or Chemical Engineering with 10+ years of relevant experience in molecule drug product development, scale-up, and technical transfer.
• A minimum of 5 years hands-on experience in development and manufacture of injectable products. Experience in fill-finish and lyophilization technologies.
• Expert level knowledge of drug development principles and practice. Working knowledge of analytical testing of products.
Strong knowledge of requirements for drug product manufacture as well as broader drug development guidelines and regulations (ICH, FDA, and EMA).
• Demonstrated experience in setting up contracts and leading projects remotely. Strong project management skills required.
• Excellent oral and written communication skills for presenting in project meetings, vendor discussions, and writing technical reports and regulatory documents.
• Periodic travel to support manufacturing operations will be required (approximately 20% of time).