Senior Scientist, I - Drug Substance Analytical R&D
Core
Developing and optimizing analytical methods for drug substance (active pharmaceutical ingredient) programs from pre-clinical through first-in-human clinical stages.
Role type
Senior Scientist I, Drug Substance Analytical R&D
Builds
Analytical methods, technical transfer packages, and data supporting regulatory requirements for small-molecule drug substances.
Domain
Pharmaceutical R&D, Analytical Chemistry, Small-molecule drug development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development and optimization, Impurity profiling, Chromatographic analysis (HPLC/GC), Spectroscopic techniques, Organic chemistry fundamentals, GxP compliance, Data interpretation and visualization
Preferred skills
Synthetic organic chemistry knowledge, Peptide analysis and SPPS experience, Troubleshooting analytical methods, Cross-functional collaboration
Technologies
HPLC, GC, Computerized data handling systems
Responsibilities
Apply analytical separation and detection modes for complex impurity profiling of pharmaceutical drug substances. Lead 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. Formulate conclusions and design follow-on experiments based on multidisciplinary data. Process, interpret, and visualize data to facilitate project team decisions.
Seniority
Senior, hands-on IC