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Analytical HPLC GMP Chemist

 

 

Apex Life Sciences is currently seeking an experienced Chemist. The ideal candidate is someone with 2+ years pharma exp. with HPLC, GC, and AA. UPLC would be a plus. Empower would be a plus. 

 

Main Responsibilities

  • Validate methods for various analytical techniques. 
  • Draft and review technical documents supporting development and release such as method validation/verification protocols and reports, and testing data sheets.
  • Manage and perform analytical testing of samples supporting incoming raw materials, in-process production, finished product and stability samples. 
  • Utilize analytical instrumentation such as FTIR, HPLC, GC, AA, and UV/VIS and have a scientific understanding of these techniques.
  • Compile data and perform trending studies on raw materials and drug product.
  • Perform instrument and method troubleshooting as needed.
  • Perform investigations on studies that have unusual results, and on out-of-trend and out-of-specification results.
  • Ability to identify and learn new analytical techniques and equipment without supervision.
  • Write, review, and update standard operating procedures and department policies as needed.
  • Perform all activities in compliance with cGLP/cGMP requirements.

 

Qualifications

 

  • Bachelor’s degree in Chemistry or related scientific discipline with approximately 3 - 5 years of relevant Analytical Chemistry experience; or an Associate’s degree with approximately 6 – 8 years Analytical Chemistry experience; preferably in QC, in the pharmaceutical industry.
  • Knowledge of Empower Preferred.

 

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