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Scientist, DMPK-Bioanalysis 



The Drug Metabolism and Pharmacokinetics (DMPK) department at Genentech is seeking a highly motivated Scientist to join the Bioanalytical (BA) function.  The DMPK-BA function is primarily responsible for overseeing regulated bioanalytical activities conducted at contract research laboratories (CROs), and ensuring overall compliance with GLP/GCP regulations to support the preclinical and clinical development of Genentech’s small molecule programs.

  • Technical monitoring during bioanalytical method development, validation, and sample analysis; overseeing method transfer between CROs

  • Reviewing validation reports, bioanalytical study reports, and experimental documentation; and archiving relevant study documents.

  • Conducting CRO evaluation and selection

  • Perform regular site visits, inspections, and SOP review

  • Internally, the individual is responsible for developing highly sensitive and specific bioanalytical methods for quantitative analysis of new chemical entities, metabolites, and biomarkers in a variety of biological matrices, reproducing developed methods in-house, and performing non-regulated quantitative bioanalysis.

  • The individuals serve as bioanalytical representatives on interdisciplinary project teams. In addition, the individuals may supervise and train junior staff to successfully perform all the above-mentioned responsibilities.



  • Doctoral degree in analytical chemistry, biochemistry, or equivalent with relevant industry experience of 0 to 3 years.

  • Demonstrated ability to work independently in a fast-paced environment, as well as in a team setting.

  • In-depth bioanalytical knowledge and extensive experience with modern analytical instrument platforms, particularly with LC-MS/MS.

  • Hands-on experience in developing and validating LC-MS bioanalytical methods using various techniques (SLE, LLE, SPE, and PP),

  • Strong ability to manage multiple studies simultaneously and be able to assist in troubleshooting when instrument or assay problems arise.

  • Good understanding of GLP/GCP regulations

  • Possess excellent oral and written communication skills.

  • Prior working experience at or with CROs is preferred.



Post Date: 3/28/2022 7:55:08 PM
┬ęPharmaceutical & BioScience Society, International; Last Modified: 5/17/2022; Admin Logon
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