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.

https://careers.gene.com/us/en/job/GENEUS202201100663EXTERNALENUS/Scientist-DMPK-Bioanalysis

Qualifications:

• 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.