Staff Scientist Assay Development

BioTalent; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

BioTalent is seeking a Staff Scientist, Assay Development in California to drive reagent formulation, assay chemistry optimization, and analytical validation for FDA-regulated molecular diagnostic products. You will work closely with cross-functional teams to ensure robust, manufacturable assay performance and contribute to commercialization strategies.

The role emphasizes stability studies, lyophilization, and validation activities, with exposure to ISO 13485 and CLSI guidelines.

Qualifications

• PhD with 5+ years in industry or MS with 8+ years of experience.
• Experience with molecular diagnostic development and FDA-regulated products preferred.
• Familiarity with Design Controls, FDA 510(k), ISO 13485, CLSI guidelines.

Responsibilities

• Reagent development and formulation for molecular diagnostics or IVD products.
• Assay chemistry optimization and analytical performance improvement.
• Stability studies, accelerated aging, shelf-life determination, and lyophilization.
• FDA-regulated product development and analytical validation.

Skills

Assay development

Molecular diagnostics

qPCR

PCR

Analytical validation

Design Controls

Industry experience

Education

PhD in a relevant field

MS in a relevant field

Tools

qPCR instruments

Lyophilization equipment

Job description

We're supporting an innovative biotechnology company developing next-generation genomics and molecular detection platforms as they look to add a Staff Scientist, Assay Development to their growing team.

This is an opportunity to play a key role in the development of FDA-regulated molecular diagnostic products, working at the intersection of assay chemistry, reagent development, validation, and commercialization.

You'll focus on reagent formulation and optimization, stability and shelf-life studies, lyophilization, and analytical validation, helping to ensure robust, reproducible, and manufacturable assay performance. The position works closely with assay development, quality, regulatory, engineering, and manufacturing teams to advance products from development through commercialization.

This is an excellent opportunity for a scientist who enjoys solving complex assay development challenges and wants to have a direct impact on bringing novel diagnostic technologies to market.

• Reagent development and formulation for molecular diagnostic or IVD products
• Assay chemistry optimization and analytical performance improvement
• Stability studies, accelerated aging, shelf-life determination, and lyophilization
• FDA-regulated product development and analytical validation
• Working knowledge of Design Controls, FDA 510(k), ISO 13485, and CLSI guidelines
• Experience with PCR, qPCR, multiplex fluorescence assays, or related molecular diagnostic technologies preferred
• PhD with 5+ years of industry experience, or MS with 8+ years of relevant experience