Job link Click to apply. Thank you!

The Drug Metabolism and Pharmacokinetics (DMPK) department at Genentech is seeking a highly motivated Scientist to join the Bioanalytical (BA) group.  The DMPK-BA group 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.

Responsibilities include, but are not limited to:

• Technical monitoring during bioanalytical method development, validation, and sample analysis; overseeing method transfer between CROs.
• Reviewing validation reports and experimental documentation; and archiving relevant study documents.
• Conducting CRO evaluation and selection.
• Reviewing CRO SOPs.
• Determine additional bioanalytical requirements if needed, and perform regular site visits and inspection.
• Internally, the individuals are 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 CRO-developed methods, and performing non-regulated quantitative bioanalysis.
• The individuals serve as bioanalytical representatives on interdisciplinary project teams. In addition, the individuals may train junior staff to successfully perform all the above-mentioned responsibilities.

Qualifications:

• Doctoral degree in analytical chemistry, biochemistry, or equivalent with relevant industry experience of 0 to 8 years. Master degree or Bachelor degree with relevant industry experience of 5-15 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.