Chemist III

Posting Date 2 months ago(8/8/2022 2:26 PM)
Requisition ID
2022-11267
Job Location(s)
West Lafayette IN United States
Position Type
Full Time
Company
Cook Biotech Inc.
Category
Scientific

Overview

Develop and validate analytical methods for drug products, placebo, and raw materials in the Cook Biotech Analytical Laboratory. Perform release testing on raw materials and finished products using United States Pharmacopoeia (“USP”) compendial methods, client methods, and methods developed in house.

Responsibilities

  • Perform Method development and method validation execution, including writing protocols and reports. Must be proficient.
  • Perform quality control routine testing for raw material/ Intermediate/ Release / Stability testing
  • Demonstrated ability to troubleshoot methods and instrumentation
  • Must have good communication skills and be able to, coordinate, and communicate with clients, both internal and external
  • Working knowledge of instrument qualification (e.g. IQ, OQ, PQ, calibration)
  • Meet internal timelines
  • Meet client expectations
  • Perform OOS investigations
  • Ability to use good judgment, diplomacy, maintain confidentiality, and exercise discretion regarding various operational matters and customer service.
  • Must be self sufficient

Qualifications

 

  • Degree in Chemistry or Chemistry related field
  • Candidate must have a least 5 years lab experience
  • Familiarity with CGMP’s and CFR 21-part 11 compliance
  • Analytical method development experience in a CGMP laboratory setting
  • Experienced with HPLC, must be proficient
  • Experienced or familiar with UV-Vis, Dissolution, FTIR, Karl Fischer, TOC, and general lab equipment
  • Empower experience is preferred, but not required

 

Physical Requirements:


• Limited exposure to hazardous chemicals used in the manufacture or development of the product

• Physical demands are typical of an office, laboratory, and classroom environment

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