The Clinical Applications Scientist will work with client laboratories as their Technical Supervisor, establishing best practices while managing optimal client experience for at least 5 client laboratories. This position will also be involved in technical problem-solving regarding validation problems and experimental designs for client validations in the clinical laboratory.
- Strong understanding of CLIA and other regulatory requirements for laboratory developed clinical tests, and their implementation at customer sites with a variety of requirements.
- Assist in development efforts for expansion of existing test efforts in compliance with applicable regulations, standards, and best-practices with guidance from the Director of Clinical Applications and Clinical Applications Manager.
- Develop strategies and products to validate client laboratories for non-standard applications of testing in conjunction with the Director of Clinical Applications and Clinical Applications Manager.
- Ability to serve as Technical Supervisor for at least 5 client laboratories.
- Build and maintain strong relationships with customers and inspectors and other stakeholders in the healthcare industry. Facilitate cross-organizational collaboration to ensure stakeholder confidence.
- Excellent communication and interpersonal skills, with the ability to build strong relationships with internal and external stakeholders.
- Stay up-to-Stay up-to-date with developments in the healthcare industry and regulatory landscape.
- Strong analytical and problem-solving skills, with the ability to make data-driven decisions.
B.S. in Biology or related science field and at least 4 years of clinical laboratory experience in high complexity molecular diagnostics. OR M.S. in Biology or related science field and at least 2 years of clinical laboratory experience in high complexity molecular diagnostics. OR Ph.D. in Biology or related science field and at least 1 year of clinical laboratory experience in high complexity molecular diagnostics.
1+ years of experience with real-time PCR.
Strong knowledge of real-time PCR platforms.
Extremely organized and deliver final product timely.
Ability to manage additional tasks as assigned.
Proficiency with Microsoft Excel and Word.