South San Francisco, California
The Drug Metabolism and Pharmacokinetics (DMPK) department at Genentech is seeking a highly motivated Senior/Principal Scientific Researcher 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.
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 interdisciplinary project teams. In addition, the individuals may supervise and train junior staff to successfully perform all the above-mentioned responsibilities.
Bachelor or Master degree in analytical chemistry, biochemistry, or equivalent with a minimum of 3 years of relevant industry experience.
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)
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.
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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