Senior Molecular Diagnostics Specialist
6 days ago
We are seeking a highly skilled Sr Biopharma Scientist to join our team at Lifelancer, a talent-hiring platform in Life Sciences, Pharma and IT. As a key member of our team, you will play a crucial role in supporting the development and validation of molecular diagnostic products.
About the RoleThis is a full-time position that requires strong analytical and problem-solving skills, as well as excellent communication and collaboration abilities. You will work closely with cross-functional teams, including R&D, Operations, Regulatory Affairs, Quality Assurance, Software and Information Technology, Laboratory Directors, and external stakeholders.
Responsibilities- Develop comprehensive assay analytical validation plans to align with regulatory agency expectations for IDE, clinical performance studies, sPMA, and PMA submissions.
- Establish standard analytical validation strategies, procedures, and best practices to maintain consistency across new development projects.
- Design, plan, write, and lead validation/verification studies, compiling and/or directing the compilation of validation/verification documents, ensuring on-time submissions to regulatory agencies.
- Support business/project proposals, e.g., new CDx intended uses with pharmaceutical partners, and respond to queries from regulatory agencies.
- Identify risk areas, develop alternative courses of action, and anticipate regulators' responses through scenario planning and contingency planning.
- Cross-functionally collaborate and coordinate with program/project managers, applicable teams, and stakeholders to achieve business objectives, deliverables, and timelines.
- Meet one of the following education and experience requirements: Ph.D. or related degree in life sciences with a minimum of 4 years of clinical molecular diagnostics experience, M.Sc. in life sciences with a minimum of 5 years of clinical molecular diagnostics experience, or B.Sc. in life sciences with a minimum of 7 years of clinical molecular diagnostics experience.
- Experience and knowledge of regulatory agency analytical validation expectations for IDE, clinical performance studies, sPMA, and PMA submissions.
- Work experience in domestic and international regulated molecular diagnostic tests, especially in analytical and/or clinical validations, e.g., US FDA-approved In Vitro Diagnostic devices, QSR, CLIA, CAP, NYSDOH, Japan PMDA, and Europe.
- Strong scientific expertise and knowledge base in molecular diagnostic testing.
- Excellent written and oral communication skills.
- Proven ability for productive cross-functional teamwork to achieve company/project goals and timelines.
$120,000 - $160,000 per annum, depending on experience and qualifications.
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