Scientist, Analytical Operations

Role Summary

Research Scientist to join the Pivotal and Commercial Biologics Characterization team within Biologics Pivotal and Commercial Analytical Development. Broad experience in analytical development across all stages—from early development to commercial launch—with regulatory filing experience and a deep understanding of technologies used in the characterization of biological products. The role focuses on biochemical characterization and development of novel analytical methods to support both clinical and commercial programs.

Responsibilities

• Define excipient and process reagent testing and control strategies across the late-phase biologics portfolio, with a focus on product stability.
• Drive continuous improvement of excipient strategies.
• Support the design, justification, and execution of end-to-end control strategy development through proactive definition of product quality targets.
• Deliver high-quality work packages to support Pivotal IND and marketing applications.
• Present findings to internal and external cross-functional teams.
• Author analytical test methods, study protocols, and technical reports.
• Independently plan and execute experiments to support development and investigations.
• Collaborate across Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development, and Technical Development to ensure timely delivery and successful commercialization of the late-stage biologics portfolio.
• Drive adoption of novel and state-of-the-art characterization technologies and approaches.

Qualifications

• BS degree in Biochemistry or a related discipline with at least six (6) years of experience OR
• MS degree in Biochemistry or a related discipline with at least four (4) years of experience
• Strong knowledge of mass spectrometry, experimental design, and assay development.
• Excellent communication skills (verbal, technical writing, and interpersonal).
• Strong organizational and planning skills.
• Ability to think critically and creatively, work independently, and resolve problems using appropriate resources.

Skills

• Mass spectrometry
• Analytical method development
• Experimental design and data analysis
• Biotechnology characterization technologies
• Python, R, JMP, Spotfire (data analysis and visualization)
• FDA and EMA regulatory filing experience

Education

• PhD in Biochemistry or a related discipline (preferred)

Additional Requirements

• Familiarity with technologies such as mass spectrometry, analytical ultracentrifugation, SEC, reversed-phase chromatography, ion exchange chromatography, capillary gel electrophoresis, light scattering, and molecular analysis.
• Knowledge of FDA and ICH guidelines related to drug substances and drug products.
• Experience with mass spectrometry analysis software (Protein Metrics, Thermo BioPharma Finder, Skyline).