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Scientist, Analytical Chemistry (US-CA-San Diego)


  • A contract manufacturing organization focused on providing high quality process development, R&D, GLP Tox lots and up to P1/P2 API GMP manufacturing services to the biopharmaceutical industry.
  •   Key Accountibilities:

  • Analytical method development to assist in chemical process development and up to P1/P2 API GMP manufacturing activities in order to support GLP Tox and regulatory filings (IND).
  • Perform R&D analytical work to address chemical stability and structure elucidation.
  • Perform forced degradation, stability studies and dissolution testing.
  • Method qualification, method validation, impurity identification, and release testing of raw/starting materials, intermediates and API.
  • Maintenance of analytical equipment including, calibration/qualification for GMP activities and system suitability testing.
  • Writing of analytical reports, SOP's and IND sections.
  • Requirements:

  • B.S. Chemistry and 10 years of experience
  • Demonstrated in-depth understanding of cGMP manufacturing for biopharmaceutical products.
  • Instrument experience - HPLC, GC, SFC, LC/MS, GC/MS