Senior Scientist, R&D Operations Job Listing at Kelly Services in Sunnyvale, CA (Job ID 9430835)

Description

Title: Senior Scientist, R&D Operations
Location: Sunnyvale, CA- 100% onsite
Shift: M-F, standard working hours
Pay: $50-$65/hr
Overview:
The Senior Scientist is responsible for on-market product support in terms of post-market activities, to evaluate the performance of products against country-specific requirements and documentation for registration that drive significant impact to the organization.

This position relies heavily on experiences gained in design and development of molecular diagnostic products and provides hands-on experiences in molecular point of care tests in an FDA-QSR and ISO13485 compliant organization.

This position is part of the R&D, Global Market Expansion group.
Responsibilities:

• Critically review study protocols and reports to assess quality, clearly identify gaps, and provide mitigations for technical documentation.
• Solve complex problems and work in a cross-functional team-based environment.
• Work collaboratively as part of a team while also working independently to produce data and meet challenging timelines and goals.
• Research, initiate and procure clinical specimens and clinical matrices for R&D projects and execute end-to-end testing until final report generation.

Requirements:

• Proficiency in microbiology and molecular lab techniques, with comprehensive training in blood-borne pathogen related lab safety and chemical lab safety.
• Experience with designing and executing experiments with clinical specimens to verify assay performance.
• Demonstrated ability to interpret federal/state/international regulations as they apply to technical documentation.
• Ability to prepare high quality technical documents on product design verification and validation for regulatory submissions.

Preferred Requirements, plus not required:

• Experienced in Design of Experiments, statistical tools, interpretation and reporting of results for analytical and clinical studies.

Education and Experience Requirements:

• Bachelor's degree in related field (e.g., Microbiology, Molecular Biology, Chemistry, Biology and Genetics) with 8+ years of relevant industrial experience OR
• Master's degree in related field with 5+ years of related work experience OR
• Doctoral degree in related field with 3+ years of related work experience.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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