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Position:
Scientist, DMPK-Bioanalysis
Employer:
Genentech
Description:
The Drug Metabolism and Pharmacokinetics (DMPK) department at Genentech is seeking a highly motivated Scientist 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.
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Technical monitoring during bioanalytical method development, validation, and sample analysis; overseeing method transfer between CROs
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Reviewing validation reports, bioanalytical study reports, and experimental documentation; and archiving relevant study documents.
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Conducting CRO evaluation and selection
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Perform regular site visits, inspections, and SOP review
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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 developed methods in-house, and performing non-regulated quantitative bioanalysis.
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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.
https://careers.gene.com/us/en/job/GENEUS202201100663EXTERNALENUS/Scientist-DMPK-Bioanalysis
Qualifications/Experience:
Qualifications:
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Doctoral degree in analytical chemistry, biochemistry, or equivalent with relevant industry experience of 0 to 3 years.
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Demonstrated ability to work independently in a fast-paced environment, as well as in a team setting.
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In-depth bioanalytical knowledge and extensive experience with modern analytical instrument platforms, particularly with LC-MS/MS.
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Hands-on experience in developing and validating LC-MS bioanalytical methods using various techniques (SLE, LLE, SPE, and PP),
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Strong ability to manage multiple studies simultaneously and be able to assist in troubleshooting when instrument or assay problems arise.
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Good understanding of GLP/GCP regulations
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Possess excellent oral and written communication skills.
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Prior working experience at or with CROs is preferred.
Location:
SOUTH SAN FRANCISCO
Contact:
johnson.ryan@gene.com
Post Date:
3/28/2022 7:55:08 PM
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