The Planet Group
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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:
Requirements:
Sr. Scientist, IVD Product Development
1330 O'Brien Dr. Menlo Park, CA 94025 US
Posted: 08/17/2022
2022-08-17
2023-01-12
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.
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