Job 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 a 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.

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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