LEAH ROBERTS
Laboratory Operations
Roswell,GA
Summary
A motivated and energetic Chief Operating Officer with a robust background in clinical laboratory operations, management, and techniques. Strong organizational skills and attention to detail, while maintaining a clear focus on overall direction. Proven ability to incorporate lean operational methodology to meet business objectives and increase revenue.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Chief Operating Officer
Ipsum Diagnostics
06.2021 - Current
- Collaborates with the VP of Business Development and CEO to execute the business strategy
- Assists with departmental budget preparation and monitoring, and meeting laboratory accreditation requirements
- Trains, manages and motivates 10 direct reports to ensure that day-to-day business operations are carried out
- Establish and implement departmental policies, goals objectives, and procedures
- Determine staffing requirements, interview, and train or oversee those personnel processes
- Ability to coordinate operations of large, technical, and office support staff
- Ability to maintain cooperative working relationships with many departments as well as the community and outside agencies
- Collaborates with the Laboratory Director and Manager to develop, validate, and onboard new clinical tests (COV-19 IDx, MPX IDx, and SSTI and Wound dermatology panels)
- Manage a 4-million-dollar payroll that included: Covid pay, time-off requests, sick leave, and FMLA
Molecular Diagnostics Manager
Ipsum Diagnostics
12.2019 - 06.2021
- Leads the development and filing of applications to state and federal regulatory agencies for laboratory assays when government approval is needed
- Manages Molecular Operation Managers and Supervisors and their work product, including but not limited to laboratory tests performance, quality, and diagnostic relevance
- Ensures high-quality performance of the laboratory, reliable Turn-Around Time, and addresses any laboratory-related issues daily
- Leads the R&D effort, developing R&D strategies and priorities
- Keeps the lab-compliant and inspection ready
Molecular Diagnostics Supervisor
Ipsum Diagnostics
04.2019 - 12.2019
- Led the Molecular Diagnostics team to develop, validate and receive EUA FDA clearance for performing RT-PCR COVID-19 testing using the QuantStudio 12K flex in a 384 format
- Performs laboratory testing on multiple specimen types (Toenails, wound swabs, vaginal swabs, and urine) using multiple molecular PCR platforms
- Implementation and validation of new assays and instrumentation (Kingfisher Flex)
- Assist in the development of new protocols
- Maintains and records metrics for quality control and assurance
Molecular Pathology Medical Technologist
Lifebrite Laboratories
01.2018 - 01.2019
- Performs routine and complex analysis of patient specimens per standard operating procedures (SOPs), following quality control protocols to ensure the accuracy of patient results
- Maintains records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens
Medical Technologist II
Children’s Healthcare of Atlanta
01.2014 - 01.2018
- Independently performs qualitative and quantitative molecular assays and report test results according to standard operating procedures
- Performs, records, and analyzes QC data; makes judgments concerning the results and takes appropriate action, when necessary, to maintain accuracy and precision
Laboratory Technician II
Genova Diagnostics
01.2011 - 01.2014
- Gives instructions for workflow to laboratory assistants
- Performs DNA extraction, PCR, and Gel Electrophoresis
Cell Manufacturing Associate
Dendreon Corporation
05.2011 - 11.2011
- Aseptically manufactured and assembled commercial human blood derived components to produce Provenge (an autologous cellular immunotherapy for prostate cancer) under the hood of a biological safety cabinet (ISO 5) in a clean room environment (ISO 7)
- Maintained batch records and logbooks to comply with regulatory requirements, manufacturing practices and aseptic processing of commercial products using Procedures
Laboratory Technician
American Red Cross
01.2008 - 01.2011
- Operated, maintained, and performed quality control on laboratory equipment including centrifuges and sterile tube welders
- Instructed new and existing staff on manufacturing procedures as a Red Cross preceptor
Education
Master of Public Health -
Walden University
2015
Bachelor of Arts - Biology
Wesleyan College
2008
Skills
- Executive Leadership
- Operation Management
- Departmental Coordination
- Policy Development
- Planning and Execution
- Process Improvement
- Attention to Quality
- Lean Methodology
- Innovative and Visionary
Certification
Medical Technologist in Molecular Biology, 2021-2024 (active) American Society for Clinical Pathology
Lean Six-Sigma Green Belt -Georgia Institute of Technology, 2016
Timeline
Chief Operating Officer
Ipsum Diagnostics
06.2021 - Current
Molecular Diagnostics Manager
Ipsum Diagnostics
12.2019 - 06.2021
Molecular Diagnostics Supervisor
Ipsum Diagnostics
04.2019 - 12.2019
Molecular Pathology Medical Technologist
Lifebrite Laboratories
01.2018 - 01.2019
Medical Technologist II
Children’s Healthcare of Atlanta
01.2014 - 01.2018
Cell Manufacturing Associate
Dendreon Corporation
05.2011 - 11.2011
Laboratory Technician II
Genova Diagnostics
01.2011 - 01.2014
Laboratory Technician
American Red Cross
01.2008 - 01.2011
Master of Public Health -
Walden University
Bachelor of Arts - Biology
Wesleyan College
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