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Scientist, Chemistry

Newark Metro Area, NJ

Posted: 06/20/2018 Job Type: Scientific Job Number: JN -062018-21873
Job Description
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.
Skills/Knowledge Required:
  • 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.
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