Position Summary

Our client is seeking a Sr. Scientist to lead development, qualification, and validation of analytical methods supporting characterization, release, and stability testing of biologics and bioconjugate (ADC) products.

Key Responsibilities

• Lead development, optimization, qualification, and validation of analytical methods (e.g., HPLC/UPLC, CE-SDS, iCIEF, ELISA, potency bioassays, mass spectrometry) supporting biologics and bioconjugate programs.
• Design and execute product characterization studies (e.g., higher-order structure, glycosylation, DAR/payload distribution for ADCs, aggregation, charge variants).
• Author and review analytical method SOPs, protocols, validation reports, and technical sections of regulatory submissions.
• Serve as the analytical subject matter expert supporting comparability studies, process characterization, and stability programs.
• Investigate atypical/out-of-specification results and lead root-cause investigations in partnership with QC and QA.
• Collaborate with process development, manufacturing, and quality teams to ensure analytical methods appropriately support process and product understanding.
• Support technology transfer of analytical methods to QC laboratories and external testing partners.
• Mentor and provide technical guidance to Scientists and Associate Scientists within Analytical Development.
• Represent Analytical Development on cross-functional program teams and in health authority interactions as needed.
• Evaluate and implement new analytical technologies and platforms to improve method capability and throughput.

Required Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, Chemistry, or a related field with 7+ years of relevant biopharmaceutical analytical experience (or M.S. with 10+ years).
• Deep expertise in biologics characterization techniques (chromatography, electrophoresis, mass spectrometry, ligand-binding/potency assays).
• Demonstrated experience developing and validating GMP analytical methods per ICH Q2(R1) guidelines.
• Strong data analysis, statistical, and troubleshooting skills.
• Excellent technical writing skills, including authorship of validation protocols/reports and regulatory sections.

Preferred Qualifications

• Experience with ADC/bioconjugate characterization (DAR determination, payload/linker analysis, free drug/payload assays).
• Experience with QbD, design space, and multivariate analysis approaches.
• Familiarity with USP/EP compendial methods and biosimilar/comparability testing.