CMC Director, Analytical Development

Position Summary

The CMC Director, Analytical Development will provide strategic and technical leadership for analytical activities supporting the development, registration, commercialisation and lifecycle management of the company’s pharmaceutical products.

The role will have responsibility for defining and delivering the analytical strategy across drug substance and drug product programmes, ensuring that analytical methods, specifications, stability programmes and associated control strategies are scientifically and phase-appropriate, compliant with regulatory expectations and suitable for commercial supply.

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

• Strategic and operational leadership of analytical activities supporting drug substance (DS) and drug product (DP) development, manufacture and commercialisation
• Developing and maintaining the analytical strategy for DS and DP from clinical development through pivotal studies, regulatory approval and commercial supply
• Acting as the analytical interface between CellCentric and its Contract Development and Manufacturing Organisations (CDMOs), contract testing laboratories, consultants and other external analytical partners
• Providing technical oversight of analytical method development, qualification, validation and lifecycle management activities
• Coordinating and overseeing analytical method transfer between development laboratories, manufacturing sites and commercial testing laboratories
• Developing and maintaining appropriate DS and DP specifications and providing analytical input into product and process control strategies
• Developing and overseeing stability programmes to support clinical development, regulatory submissions, shelf-life assignment and commercial supply
• Overseeing analytical testing to support development, process validation, stability, GMP batch release and ongoing commercial manufacture
• Ensuring analytical methods and testing laboratories are appropriately qualified and suitable to support clinical and commercial supply
• Reviewing and approving analytical protocols, reports, methods, specifications, validation documentation and other technical documentation from external suppliers
• Prioritising, troubleshooting and assisting with identifying and resolving analytical issues, including OOS/OOT results, method performance issues, stability trends and product quality investigations
• Ensuring trends in analytical and stability data are identified, assessed and actioned appropriately
• Providing analytical CMC input into regulatory strategy and drafting, reviewing and maintaining relevant sections of regulatory submissions, including IMPDs, INDs, NDAs and MAAs
• Supporting responses to analytical and CMC questions from regulatory authorities and providing analytical expertise during regulatory interactions
• Supporting selection, qualification and ongoing management of CDMOs, contract testing laboratories and analytical consultants, including participation in technical and vendor audits where required
• Managing analytical activities, timelines and external analytical budgets to ensure programme requirements are delivered to the required quality, cost and schedule
• Working closely with CMC, Quality, Regulatory Affairs, Supply Chain, Project Management and other functions to ensure analytical activities are aligned with overall development and commercialisation plans
• Supporting continuous improvement of analytical processes, systems and external testing capabilities
• Following the Company’s standard operating procedures (SOPs) and guidance

Skills and Qualifications

• Bachelor’s degree or higher in pharmaceutical sciences, chemistry, chemical engineering, or a related scientific discipline.
• Extensive pharmaceutical or biopharmaceutical industry experience with significant experience in analytical development.
• Strong technical knowledge of both drug substance and drug product analytical method development, validation, transfer, stability testing and specification development.
• Experience supporting commercial product launch and ongoing commercial supply.
• Experience supporting global regulatory submissions and interactions with FDA, EMA/MHRA and other major regulatory authorities.
• Experience establishing or qualifying analytical laboratories for clinical and commercial testing.
• Experience preparing or reviewing analytical CMC content for regulatory submissions.
• Significant experience managing CDMOs, contract analytical laboratories and other external partners.
• Excellent communication skills with the ability to communicate complex analytical issues to senior management and cross-functional teams.

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.