Kelly® Science & Clinical is seeking a Senior Scientist, Global Market Protection for a contract opportunity with a leading molecular diagnostics company at their headquarters in Sunnyvale, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.
Workplace: Onsite in Sunnyvale, CA.
Position Title: Senior Scientist, Global Market Protection
Position Type: contract until the end of 2025
Pay rate: $50-55 per hour.
Company: Kelly® Science & Clinical
Overview and Responsibilities
The Senior Scientist, R&D Operations 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.
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.
Qualifications
Proficiency in molecular lab techniques, and ability to independently design and execute lab experiments with minimal guidance or direction.
Design and execute statistically powered experiments with clinical specimens to verify assay performance.
Interpret federal/state/international regulations as they apply to our technical documentation and participate in group meetings to share weekly progress on experimentation, documentation and gap analysis.
Demonstrate ability to drive to root cause of experimental problems as they arise, and trouble-shoot with stringent hypothesis testing methods any software, hardware, assay design, or consumables issues.
Ability to prepare high quality technical documents on product design verification and validation for regulatory submissions.
Preferred
Trained and experienced in blood-borne pathogen related lab safety and microbiology lab techniques.
Experienced in Design of Experiments, statistical tools, interpretation and reporting of results for analytical and clinical studies.
Experience with technical writing.
Why Join Us:
Competitive compensation package and potential for permanent placement following the temporary period.
Opportunity to work at the forefront of biotechnology innovation in a collaborative and dynamic environment.
Access to ongoing career development and networking opportunities through Kelly® Science & Clinical's expansive network of industry experts and recruiters.
If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research.
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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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.
