Principal Scientist, Late Phase and Commercial Analytical and Formulation Development

Key Accountabilities / Core Responsibilities

• Independently lead analytical development and product characterization activities for one or more molecules in the CMC late phase/commercial space, including managing CDMO interactions and driving the development and implementation of overall analytical control strategy.
• Provide oversight of analytical method qualification, validation, and transfer activities at CDMOs, as well as method bridging, comparability, and extended characterization studies.
• Define and execute overall biologics analytical development strategy to enable accelerated CMC development and commercial timelines.
• Hands-on, technical execution in the laboratory while providing mentorship to junior colleagues.
• Develop and optimize chromatography-, capillary-, spectroscopy-, and mass spectrometry-based analytical methods for product quality assessment.
• Perform in-depth physical/chemical characterization of complex biologics.
• Lead critical quality attributes (CQAs) assessments to support phase-appropriate control system strategy.
• Provide technical guidance during testing-related investigations at CMOs/CROs in collaboration with Quality.
• Author and review technical development documents and relevant sections of health authority filings.
• Drive the establishment of internal state-of-the-art analytical capabilities to support accelerated CMC development.
• Ensure rapid and timely, cross-functional analytical support for all relevant CMC-related deliverables.
• Maintain proficiency in the latest analytical technologies and industry guidelines, as well as emerging analytical development strategies.
• Maintain timely and accurate lab records consistent with good documentation practices.
• Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.

Qualifications/Skills

• PhD in Analytical Chemistry, Biochemistry, Chemical Engineering, Biophysics, or a related scientific discipline, plus a minimum of 10 years of analytical development experience for protein therapeutics in the biotech/biopharma industry; or BS/MS with a minimum of 14 years of relevant experience.
• Previous experience successfully managing multidisciplinary analytical and quality teams to meet program milestones and timelines.
• Previous experience with large molecule late phase and commercial analytical lifecycle activities, including leading/executing successful method transfers, method qualification and validation, bridging studies, comparability and characterization studies, and supporting Quality investigations, including familiarity with applicable GMP requirements.
• In-depth knowledge and extensive hands-on experience in developing a wide array of analytical protein characterization and biophysical methods (e.g. HPLC-based methods, cIEF, capillary electrophoresis, LC/MS, peptide mapping, spectrophotometry, SPR, light scattering, etc.).
• Strong background in developing mass spectrometry-based methods (Intact/reduced MS, peptide mapping, N-/O-glycosylation profiling, disulfide linkage determination, LC-MS/MS analysis) for protein sequence confirmation, identification and characterization of product variants, and comparability evaluations considered highly preferable.
• Prior experience developing bioanalytical assays or advanced/specialized mass spectrometry characterization approaches, such as tandem mass spectrometry, quantitative analysis, and host cell protein analysis, is considered a plus.
• Strong grasp of statistical approaches for design-of-experiments (DoE) analytical method development, robustness testing, and data analysis.
• Strong grasp of relevant current industry guidelines (ICH, Pharmacopeia, FDA/EMA guidance) and best practices (BioPhorum or other consortia white papers).
• Demonstrated ability to work effectively and collaboratively with other scientists on cross-functional projects teams as well as CDMOs.
• Ability to make thoughtful and meaningful recommendations and/or manage relationships in order to drive efficient advancement of the portfolio.
• Ability to balance competing priorities and thrive in a dynamic, fast-paced environment.
• Excellent critical thinking, scientific problem-solving, and organizational skills.
• Excellent oral and written communication skills.
• Motivated, detail-oriented, scientifically driven individual with a creative approach to problem solving.