Newark Metro Area, NJ
- 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.
Contribute data for preparation of development, validation and technology transfer reports.
Performs troubleshooting within method guidance.
Performs release and stability testing in accordance with established methods, specifications and protocols with limited supervision.
Documents laboratory work that is detailed, timely and in compliance with GLP/GMP requirements.
Responsible for assisting in method development, conducting method validation, performing laboratory research and/or routine sample analysis under minimal guidance of a supervisor.
Experience with HPLC, GC, FT-IR, KF etc. required.
Knowledge of Dissolution methods developing and testing
In-depth knowledge of cGLP/GMP; applicable FDA and ICH guidances a must
Familiar with USP and other compendia
Working knowledge of Empower required.
Must have working familiarity with cGMP practice and safety awareness for analytical laboratories.