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Sr. Scientist, IVD Product Development

Menlo Park, CA 94025

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

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.
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