Genalyte, Inc. · 15 hours ago
Research Associate I/II, Validation
San Diego, CA
Full-time
Onsite
Entry, Mid Level
$31.50/hr - $39/hr
2+ years expGenalyte, Inc. is revolutionizing diagnostic testing to empower a healthier future. The Research Associate I/II will assist in the design, optimization, and validation of new immunoassays, contributing to verification and validation activities for multiple systems while working under direct supervision.
BiotechnologyHealth CareHospitalReal Time
Responsibilities
Follows established procedures to assist in design analysis on components and/or assemblies to assist in the development process of quantitative immunoassays for submission to the FDA for 510(k) clearance assessing the product under design control process from concept to product launch
Works under the guidance of a supervisor or senior team member and follows provided instructions to manage laboratory equipment and coordinate test station setups in support of product development, in accordance with established procedures
Analyze data for assay and process improvement and report findings to team and senior leadership
Executes experiments and validation protocols, supports problem-solving and trouble-shooting activities with guidance from Team Lead & Manager
Meet milestones for product development timelines
Work as part of a multi-disciplinary team with other chemists, data scientists, engineers and manufacturing personnel
Maintain compliance with all company policies, quality systems, design control and procedures
Document results, protocols, SOPs, etc
Supports product improvement and manufacturing optimization
Qualification
Required
A 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
Standard assay laboratory equipment (pipets, microscales, vortexers, centrifuges, etc.)
General presentation & spreadsheet analysis software
Preferred
Experience with FDA and 510(k) submission process
Analytical chemistry equipment (fluorimeters, spectrophotometers, chromatography, etc.)
Benefits
Health, dental, and vision insurance
Generous paid time off
Stock ownership
Equity participation
Participation in our annual target bonus plan
Company
Genalyte, Inc.
Genalyte delivers accurate, real-time blood diagnostics at the point of care. For more information, visit www.genalyte.com.
51-200 employees
H1B Sponsorship
Genalyte, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
2021 (4)
2020 (3)
Funding
Current Stage
Growth StageTotal Funding
$154.8MKey Investors
VerilyKhosla VenturesClaremont Creek Ventures
2023-03-07Series C· $13M
2021-01-11Series Unknown· $50M
2016-11-20Series D· $36M
Leadership Team
R
Rufus Burlingame
VP Clinical Assay Development
Cary Gunn
Founder
Recent News
2025-05-29
2025-04-02
Google Patent
2025-02-08
Company data provided by crunchbase