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 Senior Program Manager is key for overseeing and driving the successful execution of Genalyte’s core product development programs. This position requires a strategic thinking with exceptional project management skills, a strong technical acumen coupled with an understanding of business operations, and the ability to lead and inspire cross-functional teams.
ESSENTIAL FUNCTIONS & RESPONSIBILITIES
These may include but are not limited to:
- Manage development, validation and early commercialization of novel and technically complex IVD devices and assays
- Establish, implement and administer effective program management tools and processes to plan, monitor and control complex, interdisciplinary programs
- Manage 510(k) submission process for IVDs to FDA
- Recommend, implement, monitor, report and improve key program metrics including but not limited to scope, requirements, budget, resource consumption, and schedule
- Effectively communicate status of programs to executive team with program risks and mitigation factors
- Manage multiple projects and tasks simultaneously and effectively influence, negotiate, and communicate with internal and external business partners, contractors and vendors
- Directly and indirectly lead internal teams to achieve goals within stated timelines
- Maintain compliance with all company policies, quality systems, and procedures
- Perform other duties as assigned
- Bachelor's Degree in a technical discipline with 5 years experience in Project and Program management or similar. Advanced technical degree or MBA preferred
- PMP or PgMP certified or equivalent a plus
- Previous experience in the life science industry is preferred
- Demonstrated ability to create, maintain, and report program status utilizing industry standard tools
- Strong understanding of product design and process design concepts and best practices
- Has led projects from inception to launch
- Excellent leadership skills and experience leading high-performance teams required
- Comfortable with programs that cross technology boundaries of software, hardware, and IVD assay development
The base range for this role is $130,000-$160,000 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, Genaltye provides generous benefits, equity opportunities, and for some roles, participation in our annual target bonus plan.
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What We Do
Genalyte is a tech-enabled, full service CAP accredited and CLIA certified laboratory. We perform the majority of tests with our rapidly deployable mobile laboratory in under 30 minutes. Our central lab handles tests that cannot be performed onsite. All results are run through CloudLab, our proprietary tele-health platform, for quality oversight and monitoring by Clinical Lab Scientists.
Core to our mobile capabilities is the Maverick platform, which has unprecedented serological testing functionality - permitting up to 64 simultaneous immunoassays on whole blood in 15 minutes. The platform achieved FDA clearance in Oct 2019. In these unprecedented times, we have developed a rapid COVID-19 serology test for IgG and IgM antibodies, while simultaneously including flu and other respiratory illnesses for differential diagnosis.
For more information, visit www.genalyte.com.
