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Analytical Chemist

Philadelphia Metro Area, Pennsylvania

Post Date: 02/08/2017 Job ID: JN -022017-18326 Industry: Analytical Chem - Scientific
Analytical Chemist - Snr Scientist - BS, MS or PhD in Chemistry with pharmaceutical AR&D Expertise

Project leader for AR&D initiatives.
Perform physical and chemical testing on raw material, packaging materials, in-process, finished product, development batches and stability samples.

  • Requires expertise on analytical techniques and instrumentation (for example HPLC, UPLC, GC, LC-MS, Dissolution, UV-VIS, IR, .

  • Manage ANDA/NDA projects from development to approval with little or no guidance.

  • Develop and validate complex analytical methods.

  • Investigate and troubleshoot analytical issues.

  • Respond to FDA comments or deficiency letters.

  • Maintain the laboratory in compliance with SOPs, CGMPs, FDA and OSHA.

  • Write SOPs, and technical documents (Finished product specifications, packaging product specification, stability specifications, test methods, protocols and reports).

  • Periodically review SOPs for compliance with CGMPs and revise SOPs, if necessary.

  • Write and execute EQ protocols and set up Qualification program for new instruments.

  • Perform calibration and maintenance on existing equipment.

  • Prepare documents for regulatory filings of ANDA/NDA.

  • Review notebooks and raw data for CGMP compliance.

  • Bachelor in Chemistry / Pharmaceutical sciences with 5+ years, MS in Chemistry / Pharmaceutical sciences with 2-3 years or PhD in Chemistry / Pharmaceutical sciences with 0-2 years of pharma laboratory experience.

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