ALICE GRAY
Jerseyville,IL
Summary
Senior microbiology professional with 18 years of experience in clinical, manufacturing, quality, and research and development environments, including more than 13 years with bioMérieux and six years in technical leadership roles. Recognized subject matter expert in antimicrobial susceptibility testing (AST), VITEK 2 assay development, breakpoint implementation, performance investigations, and diagnostic product development in FDA- and ISO-regulated environments. Proven ability to lead complex scientific studies, troubleshoot technical issues, collaborate across multidisciplinary teams, and deliver high-quality products that improve customer outcomes and patient care. Currently pursuing a Master of Science in Clinical Microbiology.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Staff Scientist, R&D Microbiology
BIOMÉRIEUX
Hazelwood, Missouri
01.2018 - Current
- Lead development and verification activities supporting new antimicrobial susceptibility tests for the VITEK 2 platform.
- Lead implementation of updated clinical breakpoints for existing susceptibility tests, ensuring product performance and regulatory compliance.
- Serve as technical lead for complex field investigations, utilizing root cause analysis and scientific methodologies to identify and resolve issues.
- Act as subject matter expert for multiple technical areas and provide scientific guidance to local and global partners.
- Collaborate with cross-functional teams to support product development, performance improvements, and customer-focused solutions.
- Support regulatory activities through assessment of VITEK 2 performance using peer-reviewed scientific publications and internal data.
- Participate in manufacturing monitoring and continuous improvement initiatives to enhance product robustness and quality.
- Represent bioMérieux on the CLSI Quality Control Working Group and at industry scientific meetings such a STMA.
- Present findings and recommendations to cross-functional teams and facilitate changes that positively impact customer care and patient outcomes.
- Mentor team members and provide technical expertise for complex microbiological and data analysis challenges.
- Serve as a key scientific advisor for multidisciplinary teams, frequently relied upon to evaluate alternatives, recommend strategic approaches, and make technically sound decisions to support project objectives.
Lead Microbiologist/Scientist, Industrialization
BIOMÉRIEUX
Hazelwood, Missouri
01.2013 - 01.2018
- Led investigations involving QC lot performance issues using root cause analysis tools including fishbone diagrams and 5 Whys.
- Designed and executed scientific studies and process validations to support manufacturing operations and regulatory requirements.
- Authored FDA-auditable reports documenting investigation findings and corrective actions.
- Served as microbiology subject matter expert supporting Quality Control and ensuring disposition decisions protected product quality and minimized financial impact.
- Participated in Material Review Board activities and reviewed nonconforming material reports.
- Implemented process improvements that reduced QC performance-related nonconformities by approximately 30%.
- Served as liaison between R&D and manufacturing during product development activities and design reviews.
- Participated in risk assessments and updated documentation including device history files and risk analyses.
- Conducted internal and supplier audits and supported interactions with FDA auditors.
- Served as lead investigator and team member on CAPAs addressing audit observations and process improvements.
- Utilized TrackWise, MES, and Microsoft Office tools for documentation, trending, and reporting.
Technical Coordinator, Microbiology and Point of Care Testing
ALTON MEMORIAL HOSPITAL
Alton, Illinois
01.2008 - 01.2013
- Supervised microbiology and point-of-care testing operations while ensuring compliance with CAP and Joint Commission requirements.
- Oversaw quality control programs, audits, procedure development, and staff scheduling.
- Performed and interpreted microbiological cultures and susceptibility testing utilizing Siemens WalkAway and BD BACTEC systems.
- Maintained quality assurance programs to ensure accuracy and regulatory compliance.
Medical Technologist, Generalist
ANDERSON HOSPITAL
Maryville, Illinois
01.2006 - 01.2008
- Performed hematology, chemistry, coagulation, urinalysis, microbiology, and blood bank testing in a high-volume clinical laboratory.
Medical Technologist, Blood Bank
ST. JOHN'S MERCY MEDICAL CENTER
St. Louis, Missouri
01.2005 - 01.2006
- Performed compatibility testing, antibody identification, and blood component preparation in a tertiary care hospital blood bank.
Education
Master of Science - Clinical Microbiology and Cell Science
University of Florida
Gainesville, FL05-2029
School of Clinical Laboratory Science -
St. John's Mercy Medical Center
St Louis, MO06-2005
Bachelor of Science - Biology – Medical Technology
Southern Illinois University, Edwardsville
Edwardsville, IL05-2005
Skills
- Antimicrobial Susceptibility Testing (AST)
- VITEK 2 Platform Expertise
- Diagnostic Product Development
- Assay development
- Breakpoint Implementation
- Root cause analysis
- Experimental design
- Risk assessment
- Good Documentation Practices (GDP)
- CAPA investigations
- Data Analysis and Trending
- Root Cause Analysis and Troubleshooting
- Experimental Design and Scientific Studies
- Risk Assessment and Design Reviews
- Quality Systems
- Technical Leadership and Mentoring
- Cross-functional Collaboration
- Microsoft Office Suite
- TrackWise Digital
Certification
Medical Technologist (MT), ASCP
Timeline
Staff Scientist, R&D Microbiology
BIOMÉRIEUX
01.2018 - Current
Lead Microbiologist/Scientist, Industrialization
BIOMÉRIEUX
01.2013 - 01.2018
Technical Coordinator, Microbiology and Point of Care Testing
ALTON MEMORIAL HOSPITAL
01.2008 - 01.2013
Medical Technologist, Generalist
ANDERSON HOSPITAL
01.2006 - 01.2008
Medical Technologist, Blood Bank
ST. JOHN'S MERCY MEDICAL CENTER
01.2005 - 01.2006
Master of Science - Clinical Microbiology and Cell Science
University of Florida
School of Clinical Laboratory Science -
St. John's Mercy Medical Center
Bachelor of Science - Biology – Medical Technology
Southern Illinois University, Edwardsville