- Under general supervision, performs primarily routine testing for chromatographic and
spectrophotometric methods of analysis in support of pharmaceutical API and/or drug product.
Testing can include but is not limited to assays (potencies, related substances, residual solvents,
metals, etc.), rate of release (dissolution), moisture, identification, and other various wet
chemistry-based measurements. HPLC, UPLC and GC based methods are commonly employed
along with titrations, UV-Vis and IR -
Follows all applicable regulatory guidelines, cGMP guidelines, Environmental Health and Safety
regulations as required by the job function - Reviews analytical data, ensures accuracy of the testing procedure by following data review
checklist -
Analyzing samples from various sources to identify compounds or quantify compounds present
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Using analytical techniques and instrumentation, such as gas and high-performance liquid
chromatography (HPLC), ion chromatography, electrochromatography and spectroscopy
(infrared and ultraviolet, amongst others) - Interpreting data and adhering to strict guidelines on documentation when recording data
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Developing techniques for the analyses of drug products and chemicals, reporting scientific
results, and acting as SME for analytical techniques when needed -
Performs statistical analysis on analytical testing data of raw materials, finished products and lab
batches for hypothesis testing, trend analyses, specification etc.
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