Scientist, Analytical Development
Newark Metro Area, NJ
Responsible for assisting in method development for both API and drug product, 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. Late-phase project (NDA) experience is strongly recommended.
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, FT-IR, KF etc. required.
Knowledge of Dissolution methods developing and testing
In-depth knowledge of cGLP/GMP; applicable FDA and ICH guidance 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.
Bachelor degree minimum in Chemistry or relevant field, plus 7+ years relevant experience.