Senior Director, Biological Analytical Development

The Senior Director, Biological Analytical Development is responsible for providing both leadership and hands‑on technical expertise for analytical aspects of biologic CMC programs. This role combines strategic oversight with direct scientific contributions ensuring delivery of high‑quality methods, specifications, and regulatory documentation to enable clinical development and regulatory submissions. The role can manage a team as well as external partners/CMOs, balancing mentorship and oversight with active participation in experimental design, data interpretation, and issue resolution.

Essential Functions

• Own and drive phase appropriate analytical development strategy for biologics programs from early clinical development through commercialisation, ensuring alignment with overall CMC and Pharmaceutical Development strategy.
• Serve as the analytical CMC lead for assigned programs, providing clear scientific judgment and decision making in cross‑functional forums with Drug Substance, Drug Product, Regulatory CMC, Quality, Manufacturing, and external partners.
• Define and implement analytical control strategies across the product lifecycle, including method scope, qualification and validation approach, specifications, stability programs, reference standards, extended characterization and comparability.
• Lead analytical input into process changes, tech transfers, PPQ, and lifecycle management activities, ensuring approaches are risk based, clinically relevant, and regulator ready.
• Personally author, review, and defend key analytical sections of regulatory submissions and responses, including IND, IMPD, BLA or MAA, comparability justifications, and health authority questions.
• Govern and oversee analytical activities at external CDMOs and contract laboratories, setting expectations, reviewing data critically, addressing underperformance, and ensuring inspection readiness.
• Provide leadership to a small, senior analytical team through prioritisation, coaching, and development, while remaining sufficiently hands on to guide complex technical decisions.
• Act as a senior analytical thought partner in a lean development environment, balancing scientific rigor with pragmatism, speed, and resource constraints.
• Contribute to and in some cases lead non‑technical strategic initiatives across PharmDev or CMC, such as operating model improvements, governance processes, portfolio prioritisation, or capability strategy.
• Where required, act as a CMC Development Team Lead or deputy, integrating analytical, DS, DP, regulatory, and quality considerations into a coherent program execution strategy.
• Participate in Analytical Development and broader CMC leadership forums, contributing to strategy setting across modalities and programs.
• Communicate clearly and credibly with internal stakeholders and external partners, adapting message depth and style to technical, regulatory, and executive audiences.
• Travel as needed to support CDMO oversight, program reviews, and regulatory readiness activities.

Required/Preferred Knowledge, Skills, and Abilities

• At least 10 years experience in biologics analytical development across early and late stage development, including method qualification and validation from Phase 1 through approval.
• Demonstrated experience in biologics characterization and analytical comparability assessments supporting regulatory filings.
• Experience managing and governing external development and testing partners.
• Direct experience authoring analytical sections of regulatory submissions and addressing health authority questions.
• Preferred experience acting as a CMC Development Team Lead or senior CMC representative.
• Demonstrated ability to operate at both strategic and execution levels, with sound scientific judgment and independence of thought.
• Strong collaboration and influencing skills in matrix environments.
• Excellent written and verbal communication skills.

Required/Preferred Education and Licenses

• B.Sc. in Analytical Chemistry, Biotechnology, Biochemistry, Chemical Engineering, or a related scientific discipline required.
• M.Sc. or Ph.D. in a relevant discipline preferred.