The Laboratory Manager will manage and take responsibility for most aspects of a molecular diagnostic laboratory. This includes but is not limited to, all professional and technical aspects of the laboratory operations. The manager will plan, organize and coordinate all aspects of laboratory services. To accomplish this, the manager will use established standards of care set forth by CLIA, OSHA, the State of Maryland and other regulatory agencies to assure that the policies and procedures of the laboratory reflect the guidelines and expected standards of a clinical diagnostic laboratory.
Plans, directs, and supervises the wet lab daily production operations and ensures quality of the service in the Clinical Laboratory.
Closely monitor the NGS and PCR/qPCR pipeline QC including sample intake, nucleic acid extraction, library preparation, and sequencing
Responsible for management duties, to include budget formulation and management, ensuring regulatory compliance, quality management, employee management and staffing within the laboratory
Generate and plan annual laboratory budgets
Monitor and sustain timely maintenance and calibration of laboratory equipment to ensure optimum performance and minimum downtime.
Maintains appropriate levels of supplies, consumables, reagents, and troubleshoot instruments, assays, and reagents when problems are detected
Ensure there is a plan to keep the laboratory sustainably staffed by developing succession plans and recruiting strategies that can be implemented and evaluated on an ongoing basis.
Utilize proven employee management solutions to improve productivity and efficiency
Certify that all staff train and successfully complete competency assessments to ensure the quality and reportability of all laboratory testing performed
Responsible for reviewing and approving reports and ensuring that timelines are met
Design and direct the validations of clinical testing and instruments
Organize and conduct the initial writing of SOPs and following revisions
Interact with quality compliance officers to ensure the lab meets CLIA standard and state, local government requirements
Coordinate Production and R&D laboratory workflows, support and implement new/developing assays into production scale testing
Support and improve LIMS system
Manage partner lab relationships
Review industry news and research to help consistently implement current best practices into laboratory operations
Facilitate effective communication across internal departments by trending and reporting data
Ensure that environmental requirements are met at the federal, state, and local government levels
- Doctor of Philosophy in a chemical, physical, biological or clinical laboratory science or
- Master’s degree in a chemical, physical, biological or clinical laboratory science or medical technology or
- Bachelor’s degree in a chemical, physical, or biological science or medical technology from an accredited institution
Knowledge and Skills
- Demonstrated knowledge of federal laboratory compliance standards
- Excellent organizational skills
- COLA/CLIA regulatory expertise
- Effective data trending, document control, and technical bench skills
- Strong problem-solving, training, team building, and mentoring abilities
- Excellent written and verbal communication skills
- Strong interpersonal skills with the ability to strategize and execute
- Conceptual understanding of the microbiome and next generation sequencing
- A working knowledge of Microsoft Office and Google products
- Ability to speak and communicate technical information in public
- Ability to adjust to a fast-paced work environment and industry
- With PhD – 1 year laboratory experience with 6 months high complexity clinical microbiology experience.
- With Master’s – 2 years laboratory experience with 6 months high complexity clinical microbiology experience.
- With bachelor’s degree – 4 years laboratory experience with 6 months high complexity clinical microbiology experience.
- Preferred 5 years of CLIA laboratory experience.
- Minimum 2 years as a laboratory manager.
- Ability to travel at least 30% of time
- Physical stamina as you will often spend hours on your feet performing various tests
- Ability to carry up to 50 pounds
Position Type: Full-Time
Compensation is market competitive, and based on the experience and the expertise of the selected candidates. The candidate should have a legal work permit to work in the US. Interested candidates are invited to send their CV and cover letter to firstname.lastname@example.org