Immunoassay R&D & V&V Associate II (4/10, Equity)

Genalyte, Inc.; San Diego (CA); Vor Ort; USD 44.000 - 50.000; Vollzeit

Benefits dieser Stelle

Equity participation

Bonus program

Comprehensive benefits

Zusammenfassung

Genalyte, Inc. in San Diego is seeking a Research Associate II to support designing, optimizing, and validating new immunoassays on the Merlin platform. You will verify and validate products, contribute to V&V activities, and help improve products exiting development.

The role requires attention to detail and cross-functional collaboration, with a four-day 10-hour workweek Sunday through Wednesday. The position offers equity participation, a target bonus plan, and comprehensive benefits.

Qualifikationen

• 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 team direction and mentorship.
• Experience with FDA and 510(k) submission process preferred.
• Standard assay laboratory equipment (pipets, microscopes, etc.).
• Analytical chemistry equipment preferred.

Aufgaben

• Follows established procedures to assist in design analysis on components and assemblies for quantitative immunoassays for FDA 510(k) submission.
• Manages laboratory equipment and test station setups per procedures.
• Analyze data for assay and process improvement and report findings to team and leadership.
• Executes experiments and validation protocols with guidance from Team Lead & Manager.
• Meets milestones for product development timelines.
• Collaborates with chemists, data scientists, engineers and manufacturing personnel.
• Maintains compliance with company policies, quality systems, design control and procedures.
• Documents results, protocols, SOPs, etc.
• Supports product improvement and manufacturing optimization.

Kenntnisse

Assay development

Design control

FDA 510(k) submission

GDP/GMP/GLP

Mentorship

Team collaboration

Data analysis

Ausbildung

Bachelor’s degree in Biology or Chemistry

Tools

Pipettes & lab equipment

Analytical instruments

Jobbeschreibung

Genalyte, Inc. in San Diego is seeking a Research Associate II to support designing, optimizing, and validating new immunoassays on the Merlin platform. You will verify and validate products, contribute to V&V activities, and help improve products exiting development.

The role requires attention to detail and cross-functional collaboration, with a four-day 10-hour workweek Sunday through Wednesday. The position offers equity participation, a target bonus plan, and comprehensive benefits.