Senior Research Scientist
3 weeks ago
We are seeking a highly skilled Technology Development Scientist to join our team at Guardant Health. As a key member of our Product Development group, you will play a critical role in supporting assay development and validation, ensuring the launch of new products and companion diagnostics.
The successful candidate will have strong analytical skills, excellent interdisciplinary communication abilities, and a detail-oriented approach to work. With opportunities to assist in product development, transfer of assays to the clinical laboratory, and post-launch support, this position offers a unique chance to make a meaningful impact on patient care.
Key Responsibilities:
- Design, execute, and analyze validation studies, ensuring clear and comprehensive documentation of results in compliance with Quality Systems and Good Laboratory Practices.
- Perform hands-on laboratory work, including the development, optimization, and troubleshooting of assays, devices, or technologies.
- Lead or contribute to the preparation of technical documentation and regulatory submissions, including device master records, risk assessments, and technical dossiers for regulatory bodies (e.g., FDA, CE marking, CAP/CLIA certifications).
- Manage project timelines, resources, and tasks, coordinating and presenting to both internal and external stakeholders to ensure timely and successful project execution.
- Stay current with advances in IVD technologies and regulatory guidelines, integrating best practices into product development and validation strategies.
- Ensure compliance with all relevant safety, ethical, and quality standards during product development and testing phases, especially as it relates to data integrity.
- Provide technical guidance to junior staff or cross-functional team members as needed.
Requirements:
- Degree in Molecular Biology, Genetics, Biochemistry, or related field. PhD preferred. Masters and Bachelors with a track record of performance in Scientist roles will be considered.
- Post-graduate industry experience in genomics or molecular biology.
- Successful candidates have 0-3 years industry experience (assuming PhD).
- Strong documentation skills, especially writing study protocols and reports.
- Excellent interdisciplinary communication skills.
- Detail-oriented with good organization.
- Self-driven and a strong team player.
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