Scientist-Analytical Chemistry; Research and Development - NJ in Summit, NJ at Apex Life Sciences

Date Posted: 5/14/2018

Job Snapshot

Job Description


Description: 

  • Responsible for assisting in method development, conducting method validation, performing laboratory research and/or routine sample analysis on API and solid oral dosage form 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, FT-IR, KF, 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. 
  • Working experience in pharmaceutical industry: 8 years for BC, 7 years for MS, or 5 years for Ph.D.