Senior/Principal Scientist – DMPK Bioanalysis

Research & Development       ·        South San Francisco, California, United States of America       ·         Full time

The Position

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.

Relocation benefits are available for this position.

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Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Job Facts

Job Sub Category: Research Biology
Schedule: Full time
Job Type: Regular
Posted Date: Sep 29th 2022
Job ID: 202207-126706

Beginning September 30, 2021, Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation. 

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