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. 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. The individuals in this function also conduct CRO evaluation and selection, review 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 inter-disciplinary project teams. In addition, the individuals may supervise and train junior staff to successfully perform all the above-mentioned responsibilities. 

The ideal candidate for the DMPK-BA Associate Scientist position typically has a doctoral degree in analytical chemistry, biochemistry, or equivalent with relevant industry experience of 1 to 3 years. The candidate needs to possess a demonstrated ability to work independently in a fast-paced environment, as well as in a team setting. The candidate should have in-depth bioanalytical knowledge and extensive experience with modern analytical instrument platforms, particularly with LC-MS/MS. The candidate is expected to have hands-on experience in developing and validating LC-MS bioanalytical methods using various techniques (SLE, LLE, SPE, and PP), and have strong multi-tasking ability to manage multiple studies simultaneously and be able to assist in troubleshooting when instrument or assay problems arise. The candidate should have a good understanding of GLP/GCP regulations, and possess excellent oral and written communication skills. Prior working experience at or with CROs is preferred.