Overview In this role you will lead the transfer of NGS-based IVD assays from R&D to Operations, ensuring robust design transfer, documentation, and regulatory compliance. You will balance hands-on lab work with data analysis and cross-functional collaboration to drive project deliverables in a fast-paced setting. You'll own validation activities, risk management, and change control to sustain on-market products. This is a hands-on position at the intersection of science, quality, and operations, offering meaningful impact on diagnostic development at scale.
Compensation / Benefits- comprehensive medical, dental, vision, life and disability plans
- free testing for employees and dependents and fertility care benefits
- pregnancy and baby bonding leave
- 401k benefits
- commuter benefits
- employee referral program
Responsibilities- Plan and execute design transfer activities including IQ/OQ/PQ, stability studies, and study protocols; analyze data and author final reports
- Support test method development and validation (TMV) and generate manufacturing specifications
- Lead quality and risk management activities (FMEAs) and maintain DHF and DMR
- Lead change control to assess impact of design updates on on-market products
- Investigate deviations, perform root cause analysis, and implement CAPA
- Collaborate with cross-functional teams (e.g., Supply Chain) to ensure materials and pipelines; present data and proposals to stakeholders
Key requirements- Ph.D. in Molecular Biology, Cell Biology, Biotechnology, Biochemistry, or related field with 2+ years industry experience; OR Master's with 5+ years; OR Bachelor's with 8+ years
- hands-on NGS workflow experience (DNA/RNA extraction, targeted enrichment, or library prep) and expertise in PCR/qPCR/multiplex PCR
- ability to design, execute, analyze, and document studies; basic statistical analysis skills
- excellent cross-functional communication and ability to present complex data to non-technical audiences
- strong time management and organizational skills with ability to handle multiple priorities
- knowledge of Design Controls, QMS, regulatory standards (FDA, ISO 13485, CLSI) in GLP/GMP environments is highly desired
- experience authoring study plans, protocols, and study reports is highly desired
- experience with JMP or similar statistical software is highly desired
- prior experience in IVD product development or commercialization is preferred
- experience in manufacturing scale-up and QC is preferred
- experience with automated liquid handling platforms (e.g., Hamilton, Tecan) is preferred
- cross-functional communication
- timely execution
- data-driven decision making
- NGS workflows (DNA/RNA extraction, targeted enrichment, library prep)
- PCR, qPCR, multiplex PCR
- Design Controls and QMS knowledge
