Role:Principal Scientist, Analytical Method Development
- Provide analytical oversight of external vendors for pre clinical and Phase I - III CMC activities for small molecule drug substance (DS) and drug product (DP).
- Develop analytical methods and conduct testing internally.
- Select and manage providers of analytical services, including analytical services embedded in contract manufacturing organizations (CMOs).
- Phase appropriate development, validation and transfer of analytical methods for raw materials, in-process control, DS and DP testing.
- Participate in the development and revision of product specifications; provide scientific input and critique of analytical results.
- Review the quality control testing of clinical trial supplies performed at CMOs.
- Analyze stability studies for DS and DP.Review CMC sections of regulatory submissions along with other functional groups.
- Participate in preparation of responses to regulatory agency questions.Ensure compliance with analytical requirements for CMC regulatory submissions.
- Familiarity with a full range of analytical techniques for characterization of pharmaceuticals including thermal methods, HPLC & GC with a variety of detection methods, wet chemical analysis, spectroscopic techniques, particle size analysis.
- Develop and grow the Analytical Research and Development department in keeping with the needs of the company.
Education, prior work experience, and specialized skills and knowledge
- Advanced degree in pharmaceutical sciences or chemistry.
- Demonstrated CMC experience managing analytical development for small molecule drug substance drug product from Phase I - Phase III.
- Strong analytical, communication, presentation, and writing skills.
- Ability to strategically plan, organize and manage multiple projects simultaneously.
- Ability to exercise independent judgment with minimal supervision.
- Ability to work cross-functionally in a fast-paced team environment.Demonstrated ability to effectively manage outsourced analytical activities.
- Demonstrated experience with regulatory submissions and communication