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Position Summary
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.
Key Responsibilities
- 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.
- Lead technical investigations and manufacturing troubleshooting.
- Drive continual process understanding and lifecycle improvements.
- Maintain a good understanding of packaging, labeling, and distribution suppliers, DP forecasts on an ongoing basis, adapting strategies as required to minimize 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 program and communicate those to DP manufacturers, as needed.
- Oversee supply of DP shipments from DP manufacturer to labeling and QP release site(s).
- Lead and oversee DP process performance qualification and validation activities.
- Input into, and manage DP budget.
- Draft and maintain regulatory submissions (IMPD/IND) for DP and respond to health authority questions.
- Provide CMC technical support for NDA/MAA submission writing.
- Provide DP support for due diligence questions and defend strategy with investors/partners.
- Provide support for submitting and maintaining the process and material patent portfolio.
- Provide QA support as a SME in DP, supporting audits and drafting/reviewing CMC specific SOP/IOP’s.
- Follow the Company’s standard operating procedures (SOPs) and guidance.
- Work collaboratively with CMC Project management, CMC Regulatory Affairs, Quality Assurance, Supply Chain, Analytical Development, Drug Substance, Clinical Operations, Commercial, External CMOs.
- Support team members through constructive feedback, mentorship, and collaboration.
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Skills and Qualifications
- 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.
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Working Behaviors (Core Expectations)
- Trust and Respect: Act with integrity, honesty, and openness to build strong, credible relationships.
- Communication and Feedback: Share information clearly, listen actively, and engage in a culture of constructive feedback.
- Accountability and Reliability: Take ownership for performance, be dependable, and support others to achieve collective goals.
- Objectivity: Align on common objectives and use facts and data to reach fair, effective decisions.
- Team Balance and Enablement: Contribute to balanced roles within the team, support delegation, and help colleagues reach their full potential.
Why Join Us?
At CellCentric, we believe success is built on great teams. By embodying these working behaviors, every member contributes to a high-performing, supportive, and inclusive culture where individuals and the business thrive together.
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