Senior Scientist Drug Substance Analytical R&D

Position Description

For the Senior Scientist I position, we are seeking a highly motivated candidate who can conceive, implement and execute novel scientific research and development. The candidate can independently develop and optimize new methods and techniques to generate reliable and reproducible data in a timely manner, demonstrate broad versatile technical expertise. He/she should possess understanding of core disciplines and support early phase development of New Chemical Entities (NCEs) drug substance in both preclinical and clinical space.

He/she will collaborate within the global Analytical R&D organization and with R&D cross‑functional partners such as Pre‑Clinical Safety (PCS), Process Chemistry, Process Engineering, Drug Product Development (DPD), and Quality Assurance (QA) and CMC‑Regulatory.

This position will focus primarily on drug substance (active pharmaceutical ingredient) programs in a dynamic environment from pre‑clinical through first‑in‑human clinical stages. The individual will independently create phase‑appropriate analytical methods to facilitate process development, assess stability, control manufacturing impurities, and enable release testing of pre‑clinical and clinical drug substances. They will work closely with synthetic organic chemists in Process Chemistry to establish appropriate proposed regulatory starting materials, design efficient control strategies, support reaction troubleshooting, and identify manufacturing impurities or degradants.

Candidates should be comfortable discussing organic chemistry topics relevant to analytical chemistry, such as stereo isomers, common functional groups, and pKa values. Experience with chromatographic analysis (such as HPLC or GC) is preferred but not required. Experience with analysis of peptides and solid‑phase peptide synthesis (SPPS) is preferred but not required.

• Apply analytical separation and detection modes for complex impurity profiling of pharmaceutical drug substances to further the understanding of emerging non‑GMP and cGMP manufacturing processes.
• Responsible for leading the analytical aspects of a project while working with other functional areas to advance projects through the development pipeline.
• Utilize understanding of a range of analytical techniques to conduct research and development studies related to small‑molecule drug substances, intermediates, starting materials, impurities, and impurity profiling.
• Support new product development with advanced method development and validation, technical transfer packages, and generation of technical data in support regulatory requirements.
• Highly autonomous and productive in performing laboratory research or method development, requiring only minimal direction from or interaction with supervisor.
• Formulate conclusions and design follow‑on experiments based on multidisciplinary data.
• May initiate new areas of investigation that are scientifically meaningful, reliable, and can be incorporated directly into a research or development program.
• Process, interpret, and visualize data to facilitate project team decisions.
• Communicate and collaborate with cross‑functional groups and departments, especially process chemistry, process engineering, and technical operations.
• Routinely demonstrate scientific initiative and creativity in research or development activities and maintain a high level of productivity in the lab.
• Responsible for method development, testing procedures, and implementation of analytical control strategies to help the advancement of drug discovery candidates.
• Raises the bar and is never satisfied with the status quo.
• Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, and GxP compliance, where applicable.

• Bachelors, Masters, or Ph.D. in Analytical Chemistry typically with minimum 10 (BS), 8 (MS), or 0‑2 (Ph.D.) years related industry experience.
• Strong technical background in chemistry, excellent analytical problem‑solving skills. Capable of independently developing and troubleshooting analytical methods.
• Demonstrated experience…