ABOUT GENALYTE

At Genalyte, we’re revolutionizing diagnostic testing to empower a healthier future. Genalyte is a San Diego-based diagnostics company developing the Merlin platform, a novel photonic ring resonator-based system designed to deliver rapid, multiplexed diagnostic results. 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.

POSITION SUMMARY

Under supervision, performs a variety of manufacturing functions including assembly and packaging of kits, reagent preparation, material management and inventory control and other duties in support of manufacturing and operations. Responsible for following SOPs, performing daily tasks in a clean room/GMP environment. May also be responsible for troubleshooting manufacturing product challenges. This is a temporary position with the possibility of conversion. This posting is intended to fill two temporary positions.

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

These may include but are not limited to

Perform all duties that are required to produce reagents, intermediate consumables and finished good kits. Duties include:

Manual manipulation of small components in the assembly of consumables items

Manual and semi-automated liquid filling and QC verification of reagents into consumables

Manual and semi-automated finished goods kitting

Reagent formulation and use in the production environment including exposure to aqueous and organic hazardous materials such as acetone and isopropanol

Material management which consists of timely transfer and replenishment of materials and/or supplies to point-of-use location

Ensure inventory accuracy

Perform precision hand placement of small components

Notify area leadership or engineering of product discrepancies

Maintain or exceed acceptable productivity levels while maintaining a consistent and acceptable level of quality

Maintain a high level of cooperation and positive interaction with team members and peers

Accurately complete all documentation associated with manufacturing processes

Maintain compliance with all company policies, quality systems, and procedures

Train to cGMP, ISO 13485 and 21 CFR part 820 requirements and perform activities in compliance with them

Able to perform all tasks above following written procedures (including assembly drawings), filling out batch records and tracking intermediate and finished goods inventory for each task. Employ cleaning procedures, aseptic processing techniques, current Good Manufacturing Practices (cGMP), in a clean room with chemical and biological safety practices including exposure to dry environments and hazardous materials

Perform other duties as assigned by area leadership

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS & ABILITIES

Prior experience in medical devices, diagnostics (IVD), or healthcare technology in a regulated environment is preferred

High School education or completion of GED with a minimum of 3 years experience in an FDA regulated environment with basic laboratory operations principles such as PPE, handling of refrigerated or frozen biological materials, handling chemically and/or biologically hazardous materials and basic laboratory equipment (an equivalent combination of experience and education may be considered)

Experience working with biological testing is a plus

Proficient in general hand and small tools, such as tweezers

Demonstrated good hand-eye coordination

Ability to apply common sense understanding to carry out detailed but involved written or oral instructions

Previous experience with pipetting and filling of well-plate preferred

Proficient computer skills and good working knowledge of Microsoft Office and Google Suite programs

Ability to perform basic math and calculations using weight measurement, volume, and distance governed by Quality documents and Standard Operating Procedures