Cranbury, NJ. Submit résumé with referencing code SAM013 to HR, Xenobiotic Laboratories, a Division of WuxiAppTec, 107 Morgan Lane, Plainsboro, NJ 08536.
ResponsibilitiesLead in Method Development, Method Validation of bioanalytical methods, Bioanalytical sample analysis, calibration and troubleshooting of LC-MS/MS, HPLC/UPLC following BMV FDA guideline; Analyze and interpret Bioanalytical project data for submission to e.g., FDA, EMA; Prepare and review Protocols, SOPs, Forms, IQ/OQ/PQ documents, analytical data, and reports utilizing Analyst software and Watson; Troubleshoot day-to-day laboratory operations; Follow and review Safety precautions and GLP in bioanalytical laboratory environments; Coordinate with sponsors, vendors, and QC, QA teams for timely completion of regulatory projects and audits.
QualificationsMust have a Master’s degree in Pharmaceutical Science, Chemistry, or Biochemistry plus 2 years’ experience in job offered. Require skills and knowledge in LC-MS/MS, HPLC/UPLC, Method Validation, BMV FDA guidance, Analyst software, GLP, Bioanalytical sample analysis.
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