Lead Senior Scientist, Assay Development & Validation

San Diego Stealth Startup

San Diego (CA)

On-site

USD 175,000 - 190,000

Full time

14 days+

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Job summary

San Diego Stealth Startup seeks a Senior Staff Scientist to provide technical leadership for assay development under design control, focusing on analytical verification and validation of LDTs. You will set validation strategy, translate product and clinical requirements into rigorous study plans, and ensure high-quality execution in a regulated setting.

The right candidate will combine strategic scientific leadership with hands-on laboratory work and collaborate across R&D, Product Management,

Qualifications

PhD or equivalent with extensive industry experience in LDT validation.
10+ years in assay development and analytical validation.
Experience advancing LDT products from development to launch.
Strong knowledge of cGMP and ISO 13485 quality systems.
Regulated clinical laboratory experience (CLIA/CAP/New York state).

Responsibilities

Own design verification and analytical validation strategy for assigned assays.
Design and lead analytical performance studies including accuracy, precision, and LOD.
Translate intended use and requirements into testable inputs and validation methods.
Maintain traceability among needs, inputs, outputs, risk controls, tests, and changes.
Perform hands-on lab work and mentor junior scientists.
Author and review development and quality documentation (plans, reports, SOPs).
Communicate risks and recommendations to cross-functional stakeholders.