Manager Commercial Production Lab (Medtech)
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Описание вакансии
TL;DR
Manager Commercial Production Lab (Medtech): Leading a team in the Commercial Production Lab to ensure high-quality execution of diagnostic genomic workflows with an accent on personnel management and regulatory compliance. Focus on monitoring KPIs, ensuring adherence to CLIA/CAP standards, and providing expert guidance on complex genetic cases.
Location: Gaithersburg, Maryland, United States (Hybrid)
Salary: $110,000 - $158,000 USD
Company
is a precision medicine company leveraging one of the world's largest rare disease datasets to redefine genomic diagnostics and accelerate discovery.
What you will do
- Directly manage and coach a team of individual contributors, focusing on personnel development, performance reviews, and accountability.
- Oversee day-to-day execution of diagnostic workflows to ensure high quality, accuracy, and timeliness.
- Ensure strict adherence to standard operating procedures and regulatory requirements, including CLIA and CAP.
- Act as a key resource for complex genomic cases, troubleshooting workflows and providing expert knowledge.
- Collaborate with training leads to onboard new hires and reinforce team culture and policies.
- Authorize high-complexity test results and provide clinical consultation if properly certified.
Requirements
- Degree in Molecular Biology, Genetics, Biotechnology, Genetic Counseling, or PhD/MD/DO in a related field.
- Relevant experience: 5+ years with a Bachelor's, 2+ years with a Master's, or 1+ year with a PhD/MD/DO.
- Proven track record of leadership and management within clinical diagnostics or similarly specialized environments.
- Must be based in or able to work in Gaithersburg, MD (Hybrid).
- Required: Licensure in the state where the employee works for relevant certified positions.
- Excellent communication, writing, and critical thinking abilities.
Nice to have
- ABMGG Diplomate or equivalent certification in a specialty.
- Certified Genetic Counselor (CGC) credential from the American Board of Genetic Counseling.
Culture & Benefits
- Comprehensive health, dental, vision, and life insurance.
- 401k Retirement Savings Plan and Employee Stock Purchase Plan.
- Up to 22 weeks of fully paid parental leave (U.S.).
- Up to $25K annually for fertility, adoption, or surrogacy.
- Paid Time Off (PTO) and employee discounts.
- Dynamic environment driven by urgency and purpose to help patients get diagnosed earlier.
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