Research Associate II, Validation

Genalyte • San Diego, CA

1d

About The Position

The Research Associate II works independently under supervision to support the design, optimization, and validation of new immunoassays on Genalyte’s Merlin platform. The role performs verification and validation testing for new products and changes to released products, contributing to V&V activities across assays, reagents, consumables, instruments, and software. It calls for detail-oriented execution of tests for products exiting development, as well as support for product improvement and manufacturing optimization.

The position follows an alternative workweek schedule of four 10-hour days, Sunday through Wednesday. Work takes place in both office and laboratory environments and includes handling viral and bacterial hazards and infectious or potentially infectious bodily fluids, tissues, and samples. Minimal travel may be required, with occasional travel to clinical sites under 10%.

Requirements

• Bachelor’s degree in Biology, Chemistry, Biochemistry, or a similar field.
• At least 2 years of experience in assay development.
• Experience with design control, complex systems, and assays.
• Experience with GDP, GMP, and GLP.
• Experience with team direction and mentorship.
• Ability to use general presentation and spreadsheet analysis software.

Nice To Haves

• Experience with the FDA and 510(k) submission process.
• Experience with analytical chemistry equipment such as fluorimeters, spectrophotometers, or chromatography equipment.

Responsibilities

• Follow established procedures to assist with design analysis of components and assemblies and support development of quantitative immunoassays for FDA 510(k) clearance under design control from concept through product launch.
• Work independently under a supervisor’s or senior team member’s guidance, following instructions to manage laboratory equipment and coordinate test-station setups for product development.
• Analyze data for assay and process improvement and report findings to the team and senior leadership.
• Execute experiments and validation protocols, and support problem-solving and troubleshooting activities with guidance from the Team Lead and Manager.
• Meet product-development timeline milestones.
• Collaborate with chemists, data scientists, engineers, and manufacturing personnel as part of a multidisciplinary team.
• Maintain compliance with company policies, quality systems, design controls, and procedures.
• Document results, protocols, and standard operating procedures.
• Support product improvement and manufacturing optimization.

Benefits

• Competitive compensation, including base salary and significant equity participation.
• Eligibility for the target bonus plan.
• Comprehensive benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level