Senior Staff Scientist, Assay Development

Job overview

The Senior Staff Scientist, Assay Development is a full-time, onsite role in San Diego, California. Salary is $175,000–$190,000 per year. The scientist partners with research and development, product, clinical, laboratory operations, bioinformatics, software, quality, and regulatory teams throughout product development. The role provides technical leadership for assay development under design control, with responsibility for analytical verification and validation of laboratory-developed tests. It establishes validation strategy, leads performance studies, performs or supervises laboratory work, and ensures rigorous documentation and traceability in a regulated environment.

What you'll do

• Own or co-own assay verification and analytical validation strategy
• design and lead analytical performance studies
• translate product and clinical needs into testable design inputs
• maintain traceability across design controls and validation records
• perform or supervise laboratory work
• author and review protocols, reports, SOPs, work instructions, and quality records
• communicate technical risks and recommendations
• mentor junior scientists.

What we're looking for

Skills & competencies

san diego ca

san diego stealth startup

senior staff scientist

assay development

laboratory-developed tests

analytical validation

design controls

molecular biology

regulated laboratory

cross-functional leadership

$175k–$190k

Work arrangement

• Weekend coverage required

Why this role

Combines scientific leadership with hands-on laboratory work in a regulated diagnostic product-development environment.

About the employer

San Diego Stealth Startup is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.