Scientist I/ Scientist II, Validation at Genalyte, Inc.

ABOUT GENALYTE

At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities.

WHY WORK FOR US

We believe in investing in our employees' well-being and success. As a valued member of our team, you'll have access to a comprehensive benefits package, including competitive salary, health, dental, and vision insurance, and generous paid time off. Additionally, we offer stock ownership and equity participation, providing you with the opportunity to directly share in the success and growth of the company. Join us in shaping the future of healthcare while building a rewarding career.

POSITION SUMMARY
We are seeking a Scientist II to lead our Development & Validation operations and provide expertise across our organization on performing, developing and validating hematology, serology, and chemistry assays. In this role, you will lead with groups in R&D, Quality, Regulatory and Manufacturing. In addition to overseeing daily operational activities, you will play a significant role in product development including leading GLP studies for FDA submissions and contributing to resolving design transfer and quality control challenges. You will also participate in research collaborations internally and with external partners. This posting is intended to fill two open positions.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

These may include but are not limited to:

• 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

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• 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

The base range for this role is $100,000 - $145,000 per year. Individual pay may vary based on additional factors, including but not limited to, job-related skills, experience, work location, and relevant education or training. In addition to base salary, Genalyte provides generous benefits, equity opportunities, and for some roles, participation in our annual target bonus plan.