To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and professionals, every day.
The Advanced Development Director will supervise the development and clinical implementation of complex clinical assays and the introduction of new technologies. Responsibilities include assay design, feasibility studies, clinical validation following all regulatory guidelines (CAP, CLIA, FDA), and transference of assays to production. Additional responsibilities include optimization and monitoring quality and performance of existing methods and technologies as well as the coordination and supervision of the Advanced Development team members. The Director will also be required to attend conferences/meetings, review research publications and technologies and provide education activities such as talks and workshops for the technologists and other members of the department.
- 1. Designs and optimization of assays, reagents and instrumentation for in vitro diagnostic tests.
- 2. Supervises team of Development Technologists and Leads.
- 3. Maintenance of detailed experimental records and laboratory documentation.
- 4. Authorship of technical reports, validation summaries, SOPs and supporting quality documentation.
- 5. Design of training and troubleshooting materials to assist assay transfer to clinical lab production.
- 6. Surveillance of technology and competitive trends by review or research articles or attendance of meetings/conferences.
- 7. Efficient allocation and prioritization of time and resources to meet individual, team, and patient care goals.
- 8. Provides technical support to the clinical staff for existing assays and technology.
- 9. Understands and interprets all regulatory requirements from government agencies and private accreditation groups.
- 10. Effectively communicates ideas, progress and data to laboratory staff and leadership.
- 11. Provides educational opportunities for residents, technologists and other members of the department.
- 12. Works collaboratively with other departments and clinical laboratories under the umbrella of Yale New Haven Health and Yale University.
Doctoral degree or similar advanced degree in microbiology, molecular and cell biology, or similar biological sciences area of study with 5 or more years of post-graduate work in hospital, diagnostic laboratory or industry research and development roles.
Minimum of five (5) years of experience in a clinical or research laboratory with a minimum of 2 years of proven experience in clinical molecular assay design, validation, and implementation according to CLIA and CAP guidelines. Experience in the development of molecular infectious disease testing required as well as previous supervisory experience strongly preferred.
Certification to direct a high complexity lab preferred, but not required.
Able to work independently and in a multidisciplinary team-based environment. Attention to detail and methodical problem-solving skills. Experience with statistical methods/programs and test method validation requirements.