Newark 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 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.
- Adhere to all pertaining compliance requirements.
- Contribute data for preparation of development, validation and technology transfer reports.
- Communicates results according to project timelines and works with colleagues and collaborators to understand project needs.
- Performs troubleshooting within method guidance.
- Performs reference standard qualification/requalification tests.
- 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.
- Other duties as assigned by his/her supervisor.
- Experience with HPLC, GC, KF etc. required.
- Strong background in Dissolution method development and testing is a must
- 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.