Skip to content

Job Openings

Sr. Scientist, IVD Product Development

Menlo Park, CA 94025

Posted: 08/17/2022 Employment Type: Direct Hire/Perm Job Number: 433019-1 Country: United States Is job remote?: No

Job Description


The Senior Scientist within the Process/Product Development group will support the development, optimization, validation and documentation of new or existing NGS-based IVD products in a regulated environment (FDA-QSR, CLIA, CAP, ISO regulations). The ideal candidate should be an enthusiastic, flexible team player with IVD product development experience. 

Responsibilities:
  • Lead execution of development, verification, and validation studies for NGS-based IVD product.
  • Lead documentation effort to support QSR design control, functional specifications, performance and study results, and data management.
  • Author SOPs, work instructions, study protocols and write technical reports to support FDA submissions.
  • Manage and conduct performance qualification testing to support IVD product development and FDA submission.
  • Supervise one or two Junior/Senior Research Associates.
  • Work with the Regulatory and Quality Assurance teams to ensure that documentation meets QSR standards.
  • Establish and validate performance parameters, quality control, and stability specifications for critical reagents.
  • Support the external and internal collaboration to process samples during development and validation studies.
  • Design experiments for process characterization, performance qualification of equipment, and development activities to support FDA submission.
  • Troubleshoot and enhance existing methods, improving assay capabilities and technical robustness.
  • Maintain detailed, accurate, and accessible records of experimental data and present the results at internal meetings.

Requirements:
  • Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics with 3 years of experience or M.S. with 5 years of experience in the life sciences industry.
  • Experience with assay development and validation for IVD products.
  • Demonstrated ability to organize, document, and communicate effectively.
  • Demonstrated ability to work in a dynamic fast paced team environment. 
  • Substantial experience in optimizing laboratory methods and workflows and scaling up molecular biology assays to enable high-throughput laboratory operations.
  • Proven success in managing collaborative and individual projects.
  • Skilled at writing clear SOPs and validation reports, and experience with quality management, including design control, risk analysis, and mitigation strategies.
  • Deep understanding of essential molecular biology methods such as PCR, nucleic acids extraction and purification, quantitation, and quality control is required. Next generation sequencing experience is preferred.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet domain (@theplanetgroup.com, @theplanetforward.com, @planet-technology.com, @planet-pro.com, @planetinteractive.com, @pfes.com, @launchcg.com, @planet-pharma.com, @planet-healthcare.com) - and not a domain with an alternative extension like .net, .org or .jobs.

The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Menlo Park, CA

Ready to jumpstart your career in the vibrant heart of Menlo Park, California? Nestled in the bustling Silicon Valley, this dynamic region beckons with unparalleled growth opportunities and a thriving tech-centric environment. Unleash your potential in the epicenter of innovation, where companies like Facebook and Stanford University drive groundbreaking advancements. With the picturesque Stanford University, the iconic Menlo Park Caltrain station, and the bustling downtown area brimming with cafes and boutiques, this locale offers a blend of charm and modernity like no other. Explore career opportunities surrounded by the lush landscapes of nearby parks like Bedwell Bayfront Park or catch a game at the Stanford Stadium. Join us in discovering the endless possibilities that await in Menlo Park and unlock your career aspirations today!
Social Share Buttons and Icons powered by Ultimatelysocial