IVD Manager

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 flexible 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
The IVD Manager will be responsible for developing and validating quantitative hematology and chemistry IVD assays.  This position will lead or contribute to assay protocol development, design, execution and interpretation of validation studies and submission of analytical performance studies to the FDA.  To be successful in the role, the individual must be detail-focused and have strong project management skills. The IVD Manager will contribute to a collaborative workplace culture where we encourage honest and open communication and embrace agility while having fun. This is an onsite role and the individual may need to support studies on the weekends and outside of core working hours.  Here at Genalyte, our team members work with a sense of urgency and with a common goal of putting patients first. We prioritize transparency and continuous process improvement to contribute to the highest level of patient care. 
ESSENTIAL FUNCTIONS & RESPONSIBILITIES
These may include but are not limited to: 

• Apply previous experience in developing or validating  hematology or chemistry IVD assays to optimize assay protocols and workflows
• Organize and coordinate execution of multiple concurrent verification and validation studies, for submission to the FDA for 510(k) clearance
• Analyze data from experiments. Document experiments in lab notebook and maintain detailed and organized records
• Contribute to writing, reviewing protocols and study reports
• May train others in SOPs and other lab procedures
• Maintain compliance with all company policies, quality systems and procedures
• Perform other duties as requested

• Minimum Bachelor's Degree in biochemistry, chemistry, molecular biology or similar with 7 years of experience working on quantitative IVDs
• PhD strongly preferred
• Deep knowledge and experience in hematology or chemistry IVDs
• Deep knowledge of CLSI standards and track record of delivering analytical performance studies meeting FDA’s expectations
• Working knowledge of GMP, ISO 13485 quality systems, design verification and validation studies, and FDA regulations preferred