Senior Scientist, Analytical Development; Molecule

Senior Scientist, Analytical Development

The Senior Scientist, Analytical Development, is responsible for analytical development activities for small molecule drug substances from preclinical through commercial phase. This laboratory-focused role requires deep expertise in analytical chemistry and strong problem‑solving skills. The Senior Scientist independently manages analytical activities for assigned programs, including development, execution, validation, transfer, and troubleshooting of methods used to control raw materials, in‑process, intermediates, and final products.

The role also oversees analytical work performed at external CROs and CDMOs, conducts work in compliance with cGMP, safety, and regulatory requirements, and collaborates cross‑functionally with teams across CMC, Technical Operations, Quality, Regulatory Affairs, Manufacturing, and external partners to support product development, manufacturing readiness, and regulatory submissions.

• Perform development and optimization of phase‑appropriate analytical methods for starting materials, intermediates, and drug substances to support programs from early development through commercialization using techniques such as HPLC, GC, MS, IC, FTIR, UV, NMR, KF, and other relevant techniques.
• Perform analytical method verification and validation within cGMP compliance and in accordance with regulatory guidelines.
• Perform analytical development activities for the characterization of small molecules utilizing various chemical‑physical characterization techniques.
• Develop stability studies, forced degradation studies, and support impurity identification.
• Independently lead and execute analytical development activities and contribute to overall control strategy for assigned projects.
• Provide scientific leadership and technical support for quality investigations, including OOS/OOT events, deviations, root cause analyses, and CAPAs.
• Maintain accurate and comprehensive laboratory documentation in compliance with company procedure.
• Represent analytical development on cross‑functional teams and maintain accountability for analytical deliverables and progress on CMC and manufacturing plans.
• Conduct laboratory work independently and/or train lab personnel within the company and at external vendors.
• Support CMC regulatory documentation and filings as needed, and off‑site analytical transfers, manufacturing support, and interaction with contractors.
• Clearly communicate analytical results, risks, and recommendations through high‑quality technical reports, presentations, and cross‑functional discussions.
• Ensure safe laboratory practices and develop novel concepts and techniques to support analytical activities with chemical and product development.
• Contribute to development of policies and department strategies, build and enhance internal and external professional relationships, and support career development and technical growth of team members.

• BS/BA in Chemistry, Biochemistry, or related discipline with 5+ years of experience in the analytical/pharmaceutical development field; OR MS/MA in Chemistry or related discipline with 3+ years of experience; OR PhD in Analytical Chemistry or related discipline with relevant experience (postdoc experience acceptable).
• Hands‑on experience in method development, validation, transfer, and execution in analytical chemistry.
• Strong technical expertise in testing, method development, verification, validation, characterization, and support of stability studies for small molecule programs.
• Technical proficiency with techniques that include, but are not limited to, HPLC, UPLC, GC, KF, IC, IR, MS, spectroscopy, UV, and XRPD.
• Experience and understanding of analytical chemistry, pharmaceutical development, and phase‑appropriate control strategies.
• Excellent interpersonal skills with strong oral and written communication abilities, including drafting and reviewing technical documents.
• Excellent laboratory and productivity skills.
• Comprehensive understanding of cGMP requirements in drug substance and drug product.
• Expert knowledge of cross‑functional understanding related to drug development.
• Knowledge of FDA, EMA,…