Scientist - Analytical Chemistry
Edison-New Brunswick Metro Area, NJ
- BS. MS or PhD with a Minimum of 3+ years of relevant experience in the pharmaceutical industry - small molecules, analytical testing is required.
Extensive experience with HPLC and Dissolution testing is an absolute must
Knowledge of Dissolution methods development, GC, FT-IR, KF, etc. required.
In-depth knowledge of cGLP/GMP; applicable FDA and ICH guidances a MUST.
Familiar with USP and other compendia.
Working knowledge of Empower
Must have working familiarity with cGMP practice.
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.
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.