Perform analytical procedures and testing using HPLC, UPLC, GC, FTIR, UV-VIS spectrophotometer, and Dissolution apparatus. Conduct analytical method validation for assay and impurity profile for drug substance and drug products. Provide statistical support in optimization and validation of assay and impurity methods of analysis. Perform technical writing of controlled documents like specifications, method of analysis. Write validation protocol, reports and test methods using instrument softwares UV Win Lab, Spectrum 10ES, Empower, and Chemstation. Prepare SOPs for instruments and lab procedures. Perform qualifications and calibration of analytical instruments. Work under supervision.
Knowledge of HPLC, UPLC, GC, FTIR, UV-VIS spectrophotometer, Dissolution apparatus, UV Win Lab, Spectrum 10ES, Empower and Chem- station required. Conversant with cGLP, FDA and ICH guidelines required. Proof of knowledge required. Require a minimum of a Bachelor's degree or equivalent in statistics, chemistry or related field and 2 years of experience. Will accept a combination of a 3 year degree and/or degrees, diplomas, certificates of coursework, and/or experience determined to be equivalent to a bachelor's degree, and 2 years of experience.
Work location: Warminster, PA.
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