The DMPK Bioanalysis (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 individual in this function also conducts CRO evaluation and selection, review CRO SOPs, determine additional bioanalytical requirements if needed, and perform regular site visits and inspection.
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 CRO-developed methods, and performing non-regulated quantitative bioanalysis. The individual serves as a bioanalytical representative on inter-disciplinary project teams. In addition, the individual may supervise and train junior staff to successfully perform all the above-mentioned responsibilities.
The candidate for the DMPK-BA Senior Scientific Researcher position must have a BS/MS degree in analytical chemistry, biochemistry, or equivalent with relevant industry experience of 5 to 8 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.