Director of Molecular Assay Development
Passionate about making a difference in the world of cancer genomics?
With the advent of genomic sequencing, we can finally decode and process our genetic makeup. We now have more data than ever before but providers don't have the infrastructure or expertise to make sense of this data. We're on a mission to connect an entire ecosystem to redefine how genomic data is used in clinical settings. We are looking for a Director of Molecular Assay Development who will be responsible for leading the development of new assays and process improvements in the NGS lab.
What You’ll Do:
- Lead a team developing cutting-edge molecular assays for a high-throughput Next Generation Sequencing CAP/ CLIA/ NYSDOH-accredited clinical lab
- Lead assay validation process from project inception and scoping through product launch, including: sample selection, hands-on laboratory validation, establishing workflow and SOPs, and tech transfer to clinical lab team
- Ensure compliance with regulatory requirements
- Collaborate with cross-functional teams to determine product requirements
- Manage projects and day-to-day operations of the laboratory R&D staff
- Author clinical validation summary and regulatory documentation
- Perform hands on experiments as necessary
- Assist with development of automated processes
- Provide flexible support for other activities in the clinical Next Generation Sequencing lab including emerging technology assessment, LIMS consulting, instrument troubleshooting, etc.
- Mentor and direct scientific laboratory staff
- Previous assay development and/or validation experience required
- Project management experience highly desired
- Highly organized and systematic, superb attention to detail and ability to complete tasks with a high degree of accuracy
- Must have experience managing a team and collaborating with cross-functional groups
- Proven ability to learn new skills quickly and adapt to new processes smoothly
- Ph.D. and 6+ years experience in molecular assay development required, including experience in a clinical laboratory (preferably CAP/NYS accredited), OR Master’s degree and 8+ years relevant experience, OR Bachelor’s degree and 10+ years relevant experience