- Bulk API Manufacturing
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Consultants will be required but not limited to the following:
- Perform a wide variety of analytical chemical analyses for the release of raw materials,
intermediates, and small molecule API drug substances with a proven ability in general wet
chemistry and chromatography (HPLC, UPLC, GC)
- Perform instrument maintenance and troubleshoot equipment as needed
- Perform method development including instrument parameters, new instruments, and method
improvement studies
- Adhere to all EPA, FDA, cGMP, and DEA regulations and internal SOPs as they relate to the
operation of the Quality Control lab and general operation of the chemical production facility.
- Responsible for coverage of all job duties typical for analytical method development and
validation
- Experience with Wet Chemistry, Chromatography (HPLC, UPLC, GC) -MUST, cGMP Regulation
knowledge – PREFERRED
- Experience in small molecule environment, Extensive knowledge of analytical instrumentation –
PREFERRED
- Very busy, Growing fast.
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