South San Francisco
California, United States of America
The DMPK department is dedicated to enabling the discovery, development and commercialization of safe and effective medicines by elucidating the mechanisms of absorption, distribution, metabolism, and excretion of small molecule drug candidates. We accomplish our goals through the application of state-of-the-art technologies for bioanalysis, drug metabolism, drug transport and pharmacokinetics. The DMPK department works in close partnership with disciplines such as medicinal chemistry, in vivo pharmacology, toxicology, pharmaceutical sciences, clinical pharmacology and regulatory to optimize lead compounds, select clinical candidates, conduct preclinical studies, support clinical development and contribute to IND and NDA filings.
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.
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.
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