Associate Director, Analytical Development and Clinical QC

Key Responsibilities

• Lead multiple projects in parallel, working closely with other PDCS teams, Regulatory, QA, and external QC laboratories.
• Design the strategy of late-stage analytical activities including method transfer/validation, compendia method verification, and overall testing strategy throughout all phases of the product lifecycle.
• Author regulatory filings in relevant analytical sections with a focused understanding of country-specific requirements.
• Lead analytical QC testing, problem-solving, and data analysis for the CMC program.
• Lead independently regulatory authoring for both medical and market-facing submissions for all markets, including responses to health authority queries and requests for information.

Qualifications

• Advanced degree (PhD or MSc) in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or related field with 8–12+ years of progressive experience in biologics analytical development across clinical and commercial stages.
• Validated first-hand expert knowledge and technical proficiency with monoclonal antibodies, bispecifics, fusion proteins.
• Technical expertise in chromatography (e.g., SEC, RP, IEX), capillary electrophoresis (CE-SDS, cIEF), spectroscopy (UV/Vis, fluorescence, CD), bioassays (binding, potency), and residuals/impurities testing (HCP, DNA, residual Protein A).
• Compendia method experience emphasizing USP, EP and JP compliance.
• Strong written and verbal skills for clear reports, regulatory submissions, and presentations to technical and non-technical collaborators.
• Demonstrated success in method development, qualification/validation (per ICH Q2), transfer to QC/CMOs, and continued verification for commercial control strategies.
• Strong command of ICH (Q5E, Q6B, Q8–Q12), USP/EP, FDA/EMA expectations for biologics, GMP/GLP compliance, and authoring/reviewing CTD Module 3, IND/IMPD, BLA/MAA analytical sections and responses to agency queries.
• Proficiency with GxP compliant documentation, ALCOA+ data integrity principles, OOS/OOT handling, deviation/CAPA management, and audit readiness.