Senior Scientific Researcher - Technical Oversight of Outsourced Methods - South San Francisco, CA | Biospace
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Senior Scientific Researcher - Technical Oversight of Outsourced Methods

Genentech, Inc.

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Location:
South San Francisco, CA
Posted Date:
11/14/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Associates Degree
Areas of Expertise Desired:

Job Description


Join a Team that Lives to Improve Lives
People come to Genentech from across disciplines and across the world to solve our most challenging medical conditions. You’ll find inspiration in our passion for biotechnology, our purpose to positively impact the lives of millions of patients and our dedication to our people. Joining Genentech means being part of a tradition of inquiry that will change the world. It means embracing our failures as much as our successes. It requires a willingness to look beyond the edge of what's possible. And a focus on doing the day-to-day work that makes great science happen.

The following opportunity exists in our South San Francisco, CA headquarters:

Senior Scientific Researcher - Technical Oversight of Outsourced Methods

Description
This position will support the BioAnalytical Sciences (BAS) organization by providing technical oversight of clinical and non-clinical bioanalytical methods (LC-MS/MS, ligand binding assays (LBA), new technologies (Singulex, Quanterix, Gyros)) supporting pharmacokinetic, toxicokinetic, pharmacodynamic, immunogenicity, and biomarker analyses outsourced to Contract Research Organizations (CRO). The SSR will also review bioanalytical clinical and non-clinical study data generated at the CRO.

The Senior Scientific Researcher will support Genentech research and development projects by:
•   Being the front line technical contact with CROs for routine outsourcing activities in support of method qualifications and validations (LC-MS/MS, LBA, new technologies) and any technical questions that arise around clinical, non-clinical study data.
•   Technical oversight of outsourced methods (LC-MS/MS, LBA, new technologies) ensuring the qualified/validated state to ensure optimal assay quality
•   Monitor assay performance through data analysis and interpretation.
•   Communicate and present assay performance data and interpretation on an on-going basis to stake holders
•   Oversee incorporation and expiration extension of reagents by reviewing and approving assay data and associated documents
•   Designing and reviewing in-study validation experiments.
•   Review CRO method validation reports and addendums
•   Lead investigation of assay performance
•   May generate anti-therapeutic antibody cutpoint factors using the ATA cutpoint tool using CRO data for immunogenicity methods.
•   May coordinate cross validation experiments at CROs and generate cross validation reports.
•   Review of clinical and non-clinical study data.
•   Review CRO bioanalytical reports.
•   Lead investigation of unexpected study data.
•   May write or contribute to sections of Regulatory Documents (IND, BLA, variations, line extensions etc.)
•   May serve as a functional area project representative
•   The individual will maintain appropriate regulatory compliance in supporting clinical and non-clinical assays and studies, and will apply thorough and accurate documentation skills. The Senior Scientific

Researcher may train others on group responsibilities and systems. S/he may also be responsible for implementation or maintenance of support systems and may lead department teams charged with improving business processes

Requirements


Who You Are

Bachelor’s degree or higher in Bioanalytical Sciences, Analytical Chemistry, Biochemistry or equivalent experience and  nine years in industry and/or testing laboratory (Clinical, non-clinical, or CRO). Familiarity with bioanalytical method GxP compliance is required. The SSR will be required to have a proven technical background in developing, validating, implementing, maintaining, and troubleshooting/problem solving abilities of bioanalytical methods in one or more of the following areas: LC-MS (liquid chromatography and mass spectrometry), LBA (PK and ATA), and new technologies. Specific to LC-MS, it is desirable for the SSR to have experience with quantitative small molecule and/or protein analysis with mass spectrometric assays. Excellent communication, interpersonal and organizational skills are essential. This individual should be able to work independently as well as in a group setting, multi-task and prioritize work well.

A Job with Benefits Beyond the Benefits
No matter who you are or what role you play, you’ll help change the face of medicine and make a real difference in the lives of people facing the most challenging medical conditions. Plus, you’ll thrive in our one-of-a-kind culture, where diversity is celebrated, employees are valued for their contributions and we all serve as advocates for change who continually find ways to do things better.

The next step is yours. To apply today, click on the Apply button below.

Genentech, a member of the Roche Group, has multiple medicines on the market for cancer and other serious illnesses.

Genentech is an Equal Opportunity Employer: Minorities/Women/Disability/Veteran