The (Senior) Scientist will be responsible for leading and performing the development of analytical methods as well as the validation of the developed analytical methods. Techniques will include analysis of pharmaceutical products using HPLC, GC, Dissolution, AA, UV-Vis, X-Ray, Thermal Analysis, and wet chemical analysis.
Primary Duties and Responsibilities
- Develops methods based on client’s requirements.
- Conducts research on manufactured products to develop, improve and validate test procedures in compliance with regulatory requirements.
- Generates protocols and reports for method development, validation, and transfer.
- Conducts independent assessment of method performance and address issues.
- Devises and develops processes and methods for the solution of technical problems.
- Follows all safety rules and regulations and conducts periodic safety audits.
- Ensures all work performed follows SOPs, GMP and the regulations of the FDA and United States Pharmacopeia or other compendial methodologies.
- Supervise, train and mentor other chemists on an as needed basis.
- Provides planning and oversite on projects, establishing the approach, required resources, timing and meeting agreed timelines.
- Minimum of 2+ years of experience related to small molecule drug development.
- PhD, Masters’ and Bachelors’ candidates will be considered with appropriate years of experience working in industry (Phd = 1-2 years, Masters’ = 5+ years, Bachelors’ = 8+ years
- Experience with analytical method development, particularly with chromatographic methods.