Scientist, IVD Assay Development Job Listing at Kelly Services in Sunnyvale, CA (Job ID US3563958_BH9828950)

Description

Kelly® Science & Clinical is seeking a Senior Scientist, Assay Development for an eight-month 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, IVD Assay Development
Position Type: 8-month contract
Pay rate: $50-60/ hour.
Company: Kelly® Science & Clinical
Overview
The Senior Scientist in R&D Assay Development leads analytical and stability studies for molecular diagnostic assays targeting 510(k) submission, combining deep technical expertise in real-time PCR/RT-PCR with thorough understanding of FDA regulatory requirements.
Responsibilities

• Design and execute comprehensive analytical validation studies for molecular diagnostic assays, including precision, linearity, sensitivity / specificity, interference, and cross-reactivity studies in accordance with FDA guidelines and internal SOPs
• Develop and validate stability testing protocols for reagents and finished products, conducting real-time and accelerated stability studies to support shelf-life claims
• Author detailed study plans, technical reports, and regulatory documentation that meet FDA requirements for 510(k) submissions
• Perform hands-on laboratory work (80% of time) including assay optimization, validation testing, and troubleshooting of complex molecular diagnostic platforms
• Lead technical documentation efforts including study protocols, summary reports, and regulatory submission documents while maintaining compliance with FDA-QSR and ISO 13485 requirements

Qualifications

• Bachelor's degree in molecular biology, Biochemistry or related field with 8+ years of industry experience, OR Master's degree with 5+ years of relevant experience
• Demonstrated experience in IVD product development with direct involvement in 510(k) submissions
• Extensive hands-on expertise in real-time PCR/RT-PCR assay development and optimization
• Proven track record of designing and executing analytical validation studies for regulated medical devices

• Deep understanding of FDA requirements for molecular diagnostic devices and experience with design control processes

Preferred

• Expertise in oligonucleotide design, probe optimization, and in silico analysis
• Track record of successful regulatory submissions

This is a laboratory-focused role requiring meticulous attention to detail and the ability to work independently while adhering to rigorous quality standards. The position offers the opportunity to drive critical development programs for innovative molecular diagnostic products.
Preferred:

• Expertise in oligonucleotide design, probe optimization, and in silico analysis
• Track record of successful regulatory submissions

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.
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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 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.

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