Sr Scientist - Analytical Development

About the Role The Sr. Scientist, Analytical Development is responsible for leading analytical activities supporting clinical-stage drug substance and drug product development programs. This role provides phase-appropriate analytical development, validation, and analytical CMC regulatory support to ensure successful advancement of development candidates through clinical and commercial milestones. The Sr. Scientist will lead analytical method development and validation activities, analytical risk assessments, and control strategy development for drug substance, drug product, excipients, impurities, degradation products, and critical quality attributes. The individual will serve as a key technical contributor and cross-functional partner while providing scientific oversight of external laboratories and development organizations. Key Responsibilities Develop and execute analytical development plans aligned with CMC milestones, clinical timelines, regulatory requirements, and overall product development strategy Design, develop, optimize, qualify, validate, and transfer analytical methods for drug substance, drug product, raw materials, in-process controls, and stability testing in accordance with ICH, FDA, USP, and cGMP requirements. Lead analytical risk assessments and contribute to development of phase-appropriate analytical control strategies. Design and oversee laboratory studies and independently execute critical experiments supporting method development, validation, characterization, and investigations. Support specification development and justification through scientific evaluation of analytical and stability data. Serve as the analytical lead for assigned development programs and provide scientific leadership across cross-functional project teams. Provide technical oversight and strategic direction to external analytical laboratories, CROs, and CDMOs to ensure timely and high-quality execution of analytical deliverables. Identify critical analytical challenges, lead technical problem-solving efforts, and support root-cause investigations for OOS/OOT and product quality issues. Apply advanced analytical techniques such as HPLC/UPLC, GC, MS, LC-MS, dissolution, Karl Fischer titration, spectroscopy, particle characterization, and compendial methods as appropriate. Interpret, trend, and communicate stability data to support specification setting, shelf-life assignments, product quality assessments, and regulatory submissions. Author, review, and approve analytical development reports, specifications, and technical documents. Contribute to analytical CMC sections of IND, CTA, NDA, and other regulatory submissions. Ensure analytical activities are conducted in compliance with applicable regulatory requirements, compendial standards, and company quality systems. Review and approve analytical methods, method validation documents, release testing data, and stability results for drug products and drug substances. Collaborate closely with Regulatory, Clinical Supply, Quality Assurance, Manufacturing, and external partners to ensure alignment of analytical activities with program objectives. Stay current with emerging analytical technologies, regulatory expectations, and industry best practices and incorporate them into development strategies where appropriate. Factors for Success: PhD in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline with 4+ years of relevant pharmaceutical or biotechnology industry experience; or MS degree with 8–12 years of relevant pharmaceutical or biotechnology industry experience. Demonstrated experience supporting analytical development activities for Phase I–III clinical development programs. Experience with small peptides is a plus. Experience with sterile, ophthalmic, injectable, or other complex dosage forms preferred Experience with extractables/leachables, elemental impurities, forced degradation, characterization studies,…