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13 days old

Sr. Scientist

Kelly Services
Sunnyvale, CA 94086
**Job Title:** Senior Scientist, Oncology R&D


**Length:** 6 months (strong potential for conversion to full time)


**Compensation** : $74.52/hr


This Senior Scientist/Consultant, Oncology R&D, is a temporary, full time position (3-6 months), with high potential for becoming full time.


**POSITION SUMMARY:**


This Senior Scientist/Consultant, Oncology R&D, is a temporary, full time position (3-6 months), with high potential for becoming full time.


**ESSENTIAL JOB RESPONSIBILITIES:**


+ Bench level work focused broadly on solid tumor applications

+ Work collaboratively with Oncology R&D team members to deliver best-in-class Oncology tests

+ Develop new and/or enhance existing Oncology IVD and custom real-time PCR assays following Design and Development guidelines, including, but not limited to:Providing data driven and strategic direction to analytical experiments with solid tumor specimens

+ Study planning and data reviews with R&D, Clinical Affairs as needed.

+ Stability study planning and data reviews with Quality necessary for defining stability claims for the product and associated controls.

+ Control Limit Setting, Test Method Validation planning and data reviews with Product Transfer and Biostats necessary for defining product quality specifications.

+ Lead complex experimentation including data collection, summary and critical analysis to meet project, department and company objectives.

+ Identify strategic approaches to experimentation and develop alternative strategies as needed to maximize resource utilization.

+ Use analytical techniques to characterize factors that influence product performance and conduct optimization studies to get to the optimal design.

+ Lead team in systematic problem analysis and resolution processes for project advancement. Anticipate potential problems with preventive solutions.

+ Apply creativity and innovation in designing products that are robust and manufacturable to meet customers needs.

+ Maintain a high level of professional expertise by keeping up with current scientific literature, competing technologies and/or products

+ Maintain thorough documentation to meet QSR Design Control, as well as other international standards, such as ISO compliance and GLP/GMP requirements, etc.

+ Comply with all company safety regulations and procedures. Ensure compliance of assigned staff.

+ May be required to perform other related duties as necessary and/or assigned.


**MINIMUM REQUIREMENTS:**


PhD with 5+ years and/or MS with 8+ years and/or Bachelors with 10+ years of experience in Biology, Biochemistry, Molecular Biology, Genetics, or the equivalent education are required.


**Knowledge and skills:**


+ Experience in the development of molecular based assays with at least 6 years of experience in the Medical Device, Diagnostics or similar regulated industrial markets.

+ Excellent working knowledge and experience in implementing and following robust design control processes for CE or US-IVD tests.

+ Excellent analytical abilities and thorough understanding of statistical methods used in development of molecular methods.

+ Proven problem solving and troubleshooting abilities.

+ Strong experience with lab documentation and reporting.

+ Ability to manage, train and mentor junior and experienced research scientists.

+ Effective written and oral communication skills as well as presentation skills.

+ Persistent and flexible in response to change. Able to navigate through complexity


**Physical requirements/abilities:**


be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm/wrist motions.


**PREFERRED REQUIREMENTS:**


+ Ability to collaborate with and influence colleagues on cross-functional teams.

+ Ability to independently and strategically develop project proposals and plans.

+ Extensive assay development experience utilizing molecular technologies as well as sample processing techniques, including preanalytical factors, for solid tumor assays

+ Experience planning, directing and executing design verification studies for development of products to meet CE-IVD, FDA (510(k) and/or PMA), and other regulatory agency requirements on aggressive timelines.


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


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-02-15 Expires: 2021-03-18

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Sr. Scientist

Kelly Services
Sunnyvale, CA 94086

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