Responsibilities:
- Perform method development, testing procedures, and implementation of analytical control strategies with some guidance.
- Apply analytical separation and detection modes for complex impurity profiling to support emerging cGMP manufacturing processes.
- Contribute analytical aspects of projects and collaborate with other functional areas to advance through the development pipeline.
- Conduct R&D studies for small-molecule drug products, APIs, intermediates, starting materials, impurities, and impurity profiling.
- Support new product development via method development/validation, technical transfer packages, and generation of technical data for regulatory requirements with some guidance.
- Independently conduct laboratory research or method development with minimal supervision.
- Formulate conclusions and design follow-on experiments based on multidisciplinary data.
- Process, interpret, and visualize data to facilitate team decisions.
- Communicate and collaborate cross-functionally; demonstrate scientific rigor, initiative, creativity, and high lab productivity.
- Adhere to corporate standards for code of conduct, safety, material handling, controlled drug/radioactive compounds, and GxP compliance (where applicable).
Qualifications:
- BS in Chemistry/Analytical Chemistry (typically 7+ years) or MS (typically 5+ years).
- Strong analytical chemistry background; ability to develop/troubleshoot analytical methods with minimal guidance.
- Hands-on chromatography (HPLC/UPLC/GC) and spectroscopic techniques.
- Detail-oriented, self-motivated; ability to work in a fast-paced team environment.
- Expert Waters Empower CDS; experience with SLIMS (or similar LIMS); experience with computerized data handling systems.
- Strong written/oral communication; ability to interact with interdisciplinary scientists/engineers.
- Practical organic structure/functional groups/chemistry knowledge and modern spectroscopic techniques for small-molecule analysis.