Skills
Assay verification and validation
Design control
Regulated documentation
About the Role
We’re seeking a Senior Staff Scientist to lead analytical verification and validation for laboratory-developed tests (LDTs) in a design control, regulated environment. You’ll set validation strategy, convert product and clinical requirements into clear study plans and acceptance criteria, and ensure strong execution and documentation throughout the development lifecycle.
Responsibilities
- Define and drive verification/validation strategy for analytical performance of LDTs under design control
- Translate product and clinical requirements into study designs, acceptance criteria, and documented protocols
- Partner cross-functionally with R&D, Product Management, Clinical, Lab Operations, Bioinformatics, Software, Quality, and Regulatory
- Oversee high-quality execution of validation activities, including data review, documentation, and traceability
- Provide technical leadership while also contributing hands-on laboratory work as needed
- Ensure work aligns with applicable regulatory expectations and quality system requirements
Requirements
- Experience in analytical verification and validation for laboratory assays (LDTs preferred)
- Strong understanding of design control and regulated documentation practices
- Ability to develop study plans, define acceptance criteria, and interpret analytical performance data
- Demonstrated cross-functional leadership and communication in a product development setting
- Comfort working both strategically and operationally in the lab
Benefits
- Competitive salary range: $175,000–$190,000 per year
- Full-time role with opportunities to impact assay development end-to-end
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