Immunoassay Development Research Associate II

Genalyte, Inc; San Diego (CA); On-site; USD 44,000 - 50,000; Full time

Benefits offered by this job

Equity participation

Bonus plan

Benefits package

Job summary

Genalyte, Inc. in San Diego is seeking a Research Associate II to assist in designing, optimizing and validating immunoassays on the Merlin platform.

You will verify and validate new products and changes, contributing to V&V activities across assays, reagents, consumables, instruments, and software. The role requires attention to detail, independence under supervision, and collaboration with chemists, data scientists, engineers and manufacturing staff to meet project milestones and ensure

Qualifications

• Bachelor's degree in Biology, chemistry, biochemistry or similar with 2+ years of experience in Assay Development.
• Experience with design control, complex systems and assays.
• Experience in GDP/GMP/GLP.
• Experience with FDA and 510(k) submission process preferred.

Responsibilities

• Assist in design analysis of components for quantitative immunoassays for FDA submission.
• Coordinate test station setups and manage lab equipment for product development.
• Analyze data for assay and process improvements and report findings.

Skills

Assay development experience

Design control

GDP/GMP/GLP

Mentorship / team direction

FDA 510(k) knowledge

Data analysis

Spreadsheet proficiency

Education

Bachelor's degree in Biology/Chemistry/Biochemistry

Tools

Pipettes & lab equipment

Analytical instruments

Spectrophotometers

Chromatography

Job description

Genalyte, Inc. in San Diego is seeking a Research Associate II to assist in designing, optimizing and validating immunoassays on the Merlin platform.

You will verify and validate new products and changes, contributing to V&V activities across assays, reagents, consumables, instruments, and software. The role requires attention to detail, independence under supervision, and collaboration with chemists, data scientists, engineers and manufacturing staff to meet project milestones and ensure