Packaging and Product Executive in England

The Drug Product Director is responsible for the technical and operational leadership of the drug product throughout late-stage development, registration, validation, commercial launch and lifecycle management. Working within a virtual biotech operating model, the DP director manages outsourced manufacturing, packaging and analytical activities across multiple Contract Development and Manufacturing Organisations (CDMOs) while ensuring supply continuity, regulatory compliance and successful product launch. The role provides the technical leadership required to transition a product from Phase III clinical development into commercial manufacture, ensuring the manufacturing process, control strategy and supply chain are inspection-ready and capable of supporting global registrations. Own the overall Drug Product CMC strategy from Phase III through commercial launch; work with the project manager to turn the strategy into executable and measurable tactics. Provide technical oversight of formulation, manufacturing, packaging (in conjunction with clinical supplies when required) and stability activities. Act as the interface between CellCentric and its drug product contract manufacturing partners, negotiating contracts and providing oversight of production campaigns. Maintain a good understanding of packaging, labelling and distribution suppliers, DP forecasts on an ongoing basis, adapting strategies as required to minimise product wastage and assuring trial supply needs are met Maintain a good understanding of active pharmaceutical ingredient (API) (in conjunction with the CMC Director, drug substance) and DP timings from the clinical and commercial readiness programme and communicate those to DP manufacturers, as needed Lead and oversee DP process performance qualification and validation activities Draft and maintain regulatory submissions (IMPD/IND) and for DP and respond to health authority questions Provide CMC technical support for NDA / MAA submission writing Work collaboratively with CMC Project management, CMC Regulatory Affairs, Quality Assurance, Supply Chain, Analytical Development, Drug Substance, Clinical Operations, Commercial, External CMOs Bachelor’s degree or higher in pharmaceutical sciences, chemistry, chemical engineering, or a related scientific discipline. Significant pharmaceutical/biotechnology industry experience leading drug product development from late-stage clinical development through process validation, regulatory approval, and commercial launch of small molecule, solid oral dose pharmaceuticals. Strong technical expertise in drug product formulation, manufacturing, packaging, stability, process characterization, technology transfer, and process performance qualification. Demonstrated experience managing CDMOs and other external partners, including contract negotiation, manufacturing oversight, troubleshooting, performance management, and supply continuity. In-depth knowledge of GMP requirements and global CMC regulatory expectations, with experience supporting and drafting module 3 of IMPD/IND and NDA/MAA submissions and responding to health authority questions. Proven ability to lead cross-functional programs in a virtual or outsourced operating model, manage budgets and timelines, and communicate complex technical strategies to senior leaders and regulatory authorities. A strong understanding of analytical method development, transfer and validation would be desirable Accountability and Reliability: Take ownership for performance, be dependable, and support others to achieve collective goals. Align on common objectives and use facts and data to reach fair, effective decisions. Contribute to balanced roles within the team, support delegation, and help colleagues reach their full potential.