6 дней назад
Research Scientist II (NGS Molecular Diagnostics)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Research Scientist II (NGS Molecular Diagnostics): Leading verification and validation studies for next-generation sequencing-based molecular diagnostic solutions in a CAP/CLIA clinical laboratory environment with an accent on complex experimental design, quantitative data analysis, and regulatory submissions. Focus on designing experiments, interpreting scientific results, coordinating multidisciplinary teams, and mentoring junior research associates.
Location: La Jolla, California, United States; Monday–Friday, 8:00 AM–5:00 PM; 40 hours per week. Onsite laboratory work with approximately 5% travel, including occasional overnight or weekend travel.
Company
provides scientific staffing support for oncology research and molecular diagnostic development.
What you will do
- Lead verification and validation studies for next-generation sequencing-based molecular diagnostic product launches.
- Design and execute complex experiments, analyze quantitative data, and use findings to guide subsequent studies and project decisions.
- Coordinate study design with biostatistics, bioinformatics, regulatory, quality, medical, clinical, and laboratory operations teams.
- Prepare, review, and present technical reports and scientific findings for project teams and leadership.
- Contribute to protocol development, process improvements, regulatory compliance, quality standards, and Quality Management System procedures.
- Mentor junior research associates and provide technical and scientific guidance.
Requirements
- PhD in a field related to the role, or a related Master's degree with at least 4 years of relevant experience, or a related Bachelor's degree with at least 6 years of relevant experience.
- Experience with laboratory operations and laboratory management responsibilities.
- Demonstrated experience designing and executing complex experiments.
- Strong quantitative data analysis and scientific interpretation skills.
- Current authorization to work in the United States without employer sponsorship is required.
- Ability to perform the essential duties with or without reasonable accommodation, including fine motor laboratory work and lifting up to 25 pounds.
Nice to have
- Experience with verification and validation studies in molecular diagnostics or NGS-based testing.
- Experience in CAP/CLIA-regulated clinical laboratory environments.
- Familiarity with PMA or IDE submissions and regulated product development.
- Experience collaborating with biostatistics, bioinformatics, regulatory, quality, and clinical laboratory teams.
- Previous experience mentoring junior laboratory staff.
Culture & Benefits
- Full-time contract position with a 40-hour workweek.
- Eligible employees can access a comprehensive benefits package supporting health, well-being, and professional development.
- Cross-functional collaboration across scientific, clinical, regulatory, quality, biostatistics, and bioinformatics disciplines.
- Equal opportunity employment environment.
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