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Research Associate III: Bioanalytical Sciences (South San Francisco, CA)

Kelly Services
South San Francisco, CA 94080
Research Associate III



South San Francisco, CA



Req#: 9175935



Start: 05/01/2019



End: 05/01/2020





Duties: This contractor 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.



Skills:




+ 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.





Education:




+ Bachelor's degree or higher in Bioanalytical Sciences, Analytical Chemistry, Biochemistry or equivalent experience 5-8 years in industry and/or testing laboratory (Clinical, non-clinical, or CRO).

+ Familiarity with bioanalytical method GxP compliance is required.

+ We are looking for someone with LC MS/MS specific experience. Perferably quantitative in biological matrix.



Required Skills:




+ BIOANALYTICAL

+ CRO

+ METHOD VALIDATION



Additional Skills:




+ ATA

+ BIOCHEMISTRY

+ CHEMISTRY

+ CHROMATOGRAPHY

+ CLINICAL STUDY

+ DATA ANALYSIS

+ DOCUMENTATION

+ GYROS

+ LABORATORY

+ LIQUID CHROMATOGRAPHY

+ MAINTENANCE

+ ORGANIZATIONAL SKILLS

+ PHARMACOKINETIC

+ PROBLEM SOLVING

+ PROTEIN ANALYSIS

+ QUANTITATIVE

+ REGULATORY COMPLIANCE

+ REGULATORY DOCUMENTS

+ SPECTROMETRY

+ THERAPEUTIC








**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
Posted: 2019-08-12 Expires: 2019-09-12

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Research Associate III: Bioanalytical Sciences (South San Francisco, CA)

Kelly Services
South San Francisco, CA 94080

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