Edison-New Brunswick Metro Area, NJ
- Responsible for assisting in method development, conducting method validation, performing laboratory research and/or routine sample analysis under minimal guidance of a supervisor. Responsibilities will include, but are not limited to, the following:
- Assist senior scientist to carry out methods development, optimization and validation for the analysis of drug substances, and finished products in accordance with cGMP regulations, established protocols, and applicable SOPs.
- Experience with HPLC, GC, FT-IR, KF, dissolution, etc. required.
- Knowledge of Dissolution methods developing and testing.
- In-depth knowledge of cGLP/GMP; applicable FDA and ICH guidances required.
- Familiar with USP and other compendia.
- Working knowledge of Empower required.