Genalyte, Inc. · 11 hours ago
Scientist I/ Scientist II, Validation
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $145K/yr
5+ years expGenalyte, Inc. is revolutionizing diagnostic testing to empower a healthier future. They are seeking a Scientist II to lead Development & Validation operations, focusing on performing, developing, and validating hematology, serology, and chemistry assays while collaborating with R&D, Quality, Regulatory, and Manufacturing teams.
BiotechnologyHealth CareHospitalReal Time
Responsibilities
Draft and finalize protocols and reports for analytical studies
Lead the existing team with strong competencies in serology, chemistry and other immunoassay practices and execution of controlled performance studies
Design, develop and optimize quantitative immunoassays for submission to the FDA for 510(k) clearance assessing feasibility through initial phases and through the design control process
Analyze data for assay and process improvement and report findings to team and senior leadership
Investigate and troubleshoot problem areas to recommend product improvements
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
Manage external studies in collaboration with key opinion leaders (KOLs) and support scientific publications
Oversee collaborations with clinical trial partners, study sites, and contribute to any and all internal documents
Actively communicates project status, challenges, concerns, and resource constraints to area management
Writes design control documentation and executes/oversees associated test and risk management activities
Works with R&D to develop, optimize and integrate assay V&V
Ensures an appropriate and effective level of understanding of project needs to appropriately schedule and complete activities as committed
Supports improvement verifications, validations, and transfers
Develops, reviews, or approves execution protocols and group generated data
Oversee studies, reviews protocol execution, and approves summary reports
Qualification
Required
A minimum of a Master's degree in chemistry, biochemistry or similar with 5+ years of experience in Assay Development
Experience with team direction and mentorship
Experience with FDA and 510(k) submission process
Experience in some or all of the following areas: Antibody and protein biochemistry, surface energy modification, assay development
Experimental design (DOEs, etc), statistical analysis, power analysis, and detailed understanding of precision, uncertainty, error propagation, etc
510(k) submissions and study requirements, verification and validation of assay designs
Chemical kinetics, silicon photonics, microfluidics
Experience with large data sets & analysis & software (jmp, minitab or similar)
Working with quality assurance and quality control teams
Standard assay laboratory equipment (pipets, microscales, vortexers, centrifuges, etc.)
Analytical chemistry equipment (fluorimeters, spectrophotometers, chromatography, etc.)
Experience with protein or small molecule conjugation techniques, particle chemistry, particle size analysis and flow cytometry
Experience with development of in vitro diagnostic for biomarkers in the Point of Care setting
Demonstrated skills in carrying out innovative research with minimal guidance in an accurate, effective manner
Proven ability to functionally direct junior research staff
Experience identifying and implementing new technologies or improvements of existing technologies for any of the following: marker discovery, marker validation, product development, DFM and product manufacturing
Knowledge of scientific principals and concepts
Excellent organizational skills and ability to manage multiple tasks/projects simultaneously
Ability to plan and execute experiments to prove feasibility, develop new processes and set specifications, characterize materials and set specifications, and troubleshoot problems
Demonstrated ability to consistently meet proposed objective timelines, apply competent use of project planning and project management skills
Knowledge of quality system regulations and processes
Understand theoretical basis for analytical instrumentation
Detail-oriented and able to work with a variety of people on multiple tasks, with effective prioritization of duties
Experience identifying and implementing new technologies for marker discovery, marker validation, product development, and product manufacture is also important
Knowledgeable of federal and other regulations, e.g. QSR's, ISO, ISO 13485, CMDR
Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
General presentation & spreadsheet analysis software
Mathematical curve fitting packages
Statistical analysis software and routines
Benefits
Health, dental, and vision insurance
Generous paid time off
Stock ownership and 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