Analytical Development Chemist (Senior)


Hackensack, NJ


1969 Analytical Development Chemist

Key Responsibilities:

  • Participate in Method development and validation to include testing, protocol and report writing
  • Review data for compliance to specifications; document and investigate nonconformities
  • Perform Routine Commercial Product Release and Stability Testing
  • Lead investigations, and/or provide expertise for resolution of laboratory deviations and OOS/OOT results related to reagents and consumables
  • Ensure Good Documentation Practices for relevant QC testing procedures, and that documents are current and accurately and clearly describe processes, reagents, and acceptance criteria


  • BS/MS in Chemistry, or closely related scientific discipline
  • Proficient in Empower
  • 8-10 years relevant quality control experience
  • Strong working knowledge of ICH, cGMP, FDA and USP guidance
  • Recent experience with method development, qualification/validation and transfer preferred
  • Laboratory experience with a variety of analytical techniques including, but not limited to, GC,UV,HPLC, IR
  • Proficient in general and non-routine laboratory skills
  • Excellent computer, documentation, communication and organizational skills required
  • Must have strong attention to detail, strong problem-solving skills, as well as the ability to work in a cross-functional team environment
  • Exercises judgment within well-defined and established procedures and practices to determine appropriate action
  • Strong interpersonal and verbal/written communication skills required
  • Able to respond quickly to shifting priorities and to meet deadlines

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