Analytical Chemistry - Snr Principal Scientist
Newark Metro Area, NJ
Responsible for the development and validation of analytical methodology for the characterization and advancement of drug development.
Manages and provides support to laboratory analytical methods development, chemical characterization studies and chemical stability characterization evaluations.
- Support drug substance process development including characterization of starting materials, intermediates and final API.
- Support drug product formulation and process development including characterization of the process and finished product.
- Develop, optimize and validate analytical methods
- Support drug substance and drug product impurity characterization and identification.
- Qualify/transfer analytical methodology to quality control and contract laboratories.
- Responsible for the hiring, training, and management of technical staff
- Advanced Degree in Chemistry with 10+ years in pharmaceutical analytical development
- Academic background in Analytical Chemistry or a related chemistry discipline (e.g. Physical, Organic) with demonstrated analytical capabilities.
- Extensive laboratory experience with and an in-depth knowledge of conventional laboratory characterization techniques such as HPLC, GC, UV, IR, mass spectrometry, drug release testing, and NMR is a must.
- Hands-on proficiency with analytical methods and instrumentation.
- Fluency in more than one of the following areas is expected: synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing or pharmaceutical sciences.
- A demonstrated record of leading a high performing technical organization.