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CMC Scientist

frontage laboratories
Exton, PA Full-time
Posted on September 8, 2019

CMC Scientist

Design/develop high-quality analytical method transfer, method development, validation and verifications technology transfer, stability studies and general analytical laboratory troubleshooting and problem-solving; support new product development through analysis of innovator samples and R&D formulations; generate technical documents required for method validation and ANDA submissions; and support samples analysis including release and stability testing, impurity identification, component screening, qualification and cleaning validation pursuant to GMPs.

Requirements:

  1. Master’s or foreign equivalent degree in Chemistry, Pharmacy or a related field.
  2. 3 years experience in job offered or 3 years experience as a Scientist in the pharmaceutical industry. This required experience must include 3 years experience in analytical development for oral dosage pharmaceuticals, management of analytical development, qualifications, validation for API, excipients, dosage forms, testing and release in GMP testings, wet chemistry, physical testing of small-molecules and SOPs drafting and analytical method development/validation by using HPLC, GC, UV Spectrophotometer, ICP-OES, FTIR, IR, AA, TLC automatic titration, and dissolution apparatus.
  3. Knowledge of cGLPs and GMPs.