Busuttil Busuttil Koch
Saint Louis,MO
Summary
Regulatory and laboratory professional with 7+ years of experience supporting high-complexity clinical testing, regulatory documentation, validation, and quality systems within regulated diagnostics and healthcare environments. Proven expertise in tactical regulatory execution, including preparation, review, and lifecycle management of regulatory documentation, cross-functional coordination, audit readiness, and compliance with FDA, CLIA, CAP, CLSI, ISO, and ICH requirements. Recognized SME with strong project management, documentation control, and stakeholder communication skills, well-suited for global regulatory submission support and operational execution in a biopharmaceutical setting.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Biotechnology Laboratory Testing Scientist II / SME - Regulatory, Inventory & Kitting
C2N Diagnostics
02.2022 - 10.2025
- Supported tactical execution of regulatory-aligned laboratory operations for CLIA high-complexity testing programs across multiple assay development stages.
- Authored, reviewed, and maintained validation protocols, technical reports, and regulatory-supporting documentation, ensuring accuracy, consistency, and audit readiness.
- Led document workflows including drafting, review, approval, revision, and archival in compliance with internal quality standards and regulatory expectations.
- Partnered cross-functionally with QA, R&D, Clinical, and Operations to ensure regulatory alignment of assay validation and testing processes.
- Served as Subject Matter Expert (SME) for regulatory documentation, inventory traceability, and laboratory compliance activities.
- Monitored QC trends and performance metrics, maintaining LC-MS CVs below 4% and ensuring data integrity for regulatory review.
- Supported internal and external audits by preparing documentation, addressing findings, and implementing corrective actions.
- Developed and implemented inventory tracking systems for critical regulated materials, supporting inspection readiness and compliance.
- Mentored and trained staff on regulatory documentation practices, validation standards, and compliance expectations.
Medical Technologist II - Microbiology
Barnes-Jewish Hospital
07.2019 - 01.2022
- Executed complex microbiology testing within a regulated clinical laboratory environment, adhering to CLIA, CAP, and CLSI standards.
- Documented testing activities, deviations, and corrective actions in accordance with regulatory and institutional requirements.
- Managed and conducted CLSI quarterly/monthly audits to verify and update antibiotic breakpoint implementation, assuring regulatory compliance and patient safety.
- Supported validation and implementation of new procedures and instrumentation, including regulatory documentation and QC planning.
- Trained new personnel on testing procedures, regulatory documentation practices, and equipment operation.
Medical Technologist - Microbiology
Sunrise Medical Laboratories
03.2018 - 05.2019
- Performed moderate and high-complexity diagnostic testing in compliance with laboratory regulatory standards.
- Contributed to new test implementation, documentation updates, and workflow optimization.
- Maintained detailed records supporting traceability, quality assurance, and regulatory compliance.
Education
Advanced Certification - Medical Laboratory Technology
CUNY Hunter College
New YorkBachelor of Science - Forensic Science (Criminalistics & Toxicology)
John Jay College of Criminal Justice
New YorkAssociate in Applied Science - Electrical Engineering Technology
SUNY Nassau Community College
Garden CitySkills
- Regulatory Documentation & Submissions Support
- IND / NDA / BLA-Supporting Documentation
- Global Regulatory Compliance
- Document Lifecycle and Project Management
- Cross-Functional Regulatory Coordination
- FDA, CLIA, CAP, CLSI, ISO, ICH, CLEP Compliance
- Validation Protocols & Technical Reports
- Regulatory Audits & Inspection Readiness
- Change Control & CAPA Support
- LIMS / Document Repositories
- Scientific Principles, Assay Development, and Results Analysis
- Training and Development
Certification
- Medical Technologist (MT), American Medical Technologists (AMT)
- Antimicrobial Stewardship - Stanford Medical
- Foundations of Data Science - Google
Additional Qualifications
- Data Science Certification; familiar with SQL and Python
- Experienced with document repositories and electronic quality systems
- Strong proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat
- USMC Veteran (Honorable Discharge) - F/A-18 Electrician
Timeline
Biotechnology Laboratory Testing Scientist II / SME - Regulatory, Inventory & Kitting
C2N Diagnostics
02.2022 - 10.2025
Medical Technologist II - Microbiology
Barnes-Jewish Hospital
07.2019 - 01.2022
Medical Technologist - Microbiology
Sunrise Medical Laboratories
03.2018 - 05.2019
Bachelor of Science - Forensic Science (Criminalistics & Toxicology)
John Jay College of Criminal Justice
Associate in Applied Science - Electrical Engineering Technology
SUNY Nassau Community College
Advanced Certification - Medical Laboratory Technology
CUNY Hunter College