Edison-New Brunswick Metro Area, NJ
- Master or. Ph. D. in Chemistry.
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
- 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 to carry out method development, optimization and validation for the analysis of drug substances, and finished products in accordance with cGMP regulations, established protocols, and applicable SOPs.