Manager Commercial Production Lab

GeneDx•Gaithersburg, MD

11d•Hybrid

About The Position

The Manager leads a team within the Commercial Production Lab, providing day-to-day guidance, coaching, and support to ensure high-quality execution of diagnostic workflows. This role is responsible for fostering team performance, maintaining a culture of accountability and continuous improvement, and ensuring alignment with departmental goals. The Manager monitors key performance indicators, supports professional development, and ensures adherence to standard operating procedures. In collaboration with Functional Leads and cross-functional partners, the Manager helps drive timely completion of projects and contributes to broader operational success.

Requirements

Degree in Molecular Biology, Genetics, Biotechnology, Genetic Counseling or a related field; PhD in Biology, Genetics or related field; MD or DO with experience in human genetics plus:
At least 5 years of relevant experience with a Bachelor’s degree, including progressive leadership responsibilities.
At least 2 years of relevant experience with a Master’s degree
At least 1 years of relevant experience with a PhD, MD, or DO
Demonstrated expertise in clinical diagnostics, with a strong track record of leadership and management in roles of increasing responsibility, including experience at GeneDx or within similarly specialized environments.
Must maintain above average level of performance in duties with minimal errors. This may include, but is not limited to, demonstrating sustained above average level of performance related to quantity and quality of work being completed, dependability, teamwork, and initiative as expected for responsibilities.
Excellent writing, communication, and collaboration skills, with strong organizational, time management, and critical thinking abilities.
For relevant positions, ABMGG Diplomate or equivalent certification in a specialty may be required.
For Genetic Counselors, Master’s degree from an accredited genetic counseling program is required.
Certification by the American Board of Genetic Counseling (ABGC) or equivalent is required.
Licensure is required in the state where the employee works, if applicable; additional state licenses may be requested based on organizational needs.

Responsibilities

Directly manages a small group of individual contributors with a primary focus on personnel management.
Serves as the main point of contact for direct reports within the functional area.
Conducts regular meetings to address performance, concerns, and development needs.
Manages employee time-off requests and coordinates with functional leads to ensure adequate coverage.
Collaborates with training leads to onboard new hires and reinforce team culture, policies, and expectations.
Discusses performance goals and expectations; gathers feedback and prepares and delivers performance reviews.
Provides constructive feedback, coaching, and mentoring to support ongoing skill development.
Identifies training needs and individuals requiring additional support; participates in Performance Improvement Plans and terminations as needed.
May perform competency assessments.
Facilitates communication within the team and across functional areas.
Serves as a key resource for complex cases and questions, applying expert knowledge of processes, policies, genes, tests, and workflows.
Troubleshoots own cases and supports others in resolving issues.
Maintains high accuracy and meets workload targets with attention to detail.
Performs additional duties within validated competency scope and as assigned to support team or departmental needs.
Fulfill responsibilities of Clinical Consultant as defined by CLIA (42 CFR 493.1457), including: Consultation Availability: Provides timely consultation to ordering providers regarding test selection, interpretation, and clinical correlation of laboratory results.
Report Oversight: Reviews and ensures laboratory reports meet CLIA and CAP requirements for accuracy, completeness, and clinical relevance.
Result Authorization: Approves and signs off on high-complexity test results in accordance with CLIA regulations.
If performing clinical patient genetic counseling , maintains Certified Genetic Counselor (CGC) credential through the American Board of Genetic Counseling, Inc. and meets established standards for professional practice.
Provides genetic counseling via teleconferencing .
Participates in patient and client communication.
Supports education and competency training for laboratory staff on genetic counseling principles, regulatory requirements, and best practices.
Meets or exceeds annual continuing education requirements to maintain professional competency.
If acting as a lab supervisor as defined by CLIA, CAP, and CLEP or performing genomic analysis , responsibilities include: Providing day-to-day supervision or oversight of the laboratory operation and the personnel performing testing.
Ensuring accessibility at all times - on site, by telephone or by electronic consultation - to resolve technical problems in accordance with policies and procedures.
Monitoring the performance characteristics of tests and ensuring that acceptable levels of performance are consistently maintained.
Verifying that personnel are trained prior to performing testing on patient specimens independently.
Completing staff competency assessments at the appropriate intervals.
Ensuring action is taken when personnel do not perform as expected.