IVD Validation Manager

Here at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have a great opportunity for an IVD Validation Manager to join our team!

ABOUT THE ROLE

Genalyte is looking to hire a driven individual to join the Technology Development team as the IVD Validation Manager. This position will primarily be responsible for overseeing execution of multiple verification and validation studies by managing a team of Validation Associates. In addition, this position will aid in the design and interpretation of validation studies, and contribute to development and troubleshooting of novel IVDs. To be successful in the role, the individual must be detail-focused and have strong project management skills. The IVD Validation 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:

• Organize and coordinate execution of multiple concurrent verification and validation studies, per the approved protocols, for submission to the FDA for 510(k) clearance.

• Build a validation team capable of executing studies across multiple shifts to deliver rapid, and high quality results from a limited pool of instruments.

• Analyze data from the experiments. Document experiments in lab notebook and maintain detailed and organized records

• Contribute to writing, reviewing protocols and study reports

• Demonstrate knowledge and proficiency of procedures and regulations

• Demonstrate proficiency in performing experiments and high quality output

• Communicate complex information, orally, in writing and electronically

• Communicate material of a specialized or highly technical nature

• May train others in SOPs and other lab procedures

• Coach and mentor team members to excellence and grow their hard and soft skills to allow for advancement into new opportunities

• Build internal contacts and participate in cross functional communication for the exchange of information and collaboration including Technology Transfer, Quality Assurance and Operations

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

• Perform other duties as requested

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• Minimum Bachelor's Degree in basic biochemistry, chemistry and molecular biology labs or similar with 5 years of experience working in a biochemistry or molecular biology lab in industry and minimum 2 years of experience in performing design verification and validation studies with hand's on experience contributing to 510(k) (or similar) submissions.

• Minimum 1 year experience as a personnel manager supervising multiple employees including providing day to day direction, mentoring and reviewing performance.

• Experience with quantitative immunoassays is preferred.

• Working knowledge of GMP, ISO 13485 quality systems, design verification and validation studies, and FDA regulations preferred

BENEFITS & STOCK OPTIONS

At Genalyte, 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.

SALARY RANGE: $100,000 - $150,000

Offer decisions and base salary depend on a variety of factors including, but not limited to, an individual's skills, qualifications, business need and experience.