Michael McCleary

Background

About Michael McCleary

I am a results-driven Operations Professional driving research pharmaceutical excellence, biologics processing operations, and regulatory compliance in controlled environments. I have a proven track record managing biological and drug processing facilities, leading cross-functional teams, and implementing continuous improvement initiatives that deliver measurable results. Repository Manager/Biologics Operations Specialist at RTI International, managing secure storage and processing facilities with 24/7 responsibility. Experience spans aseptic handling of biological specimens (serum, plasma, cells, tissue, DNA), storage and security of research drug materials, and manufacturing workflow coordination for NIDA research materials and GMP operations. Technical Leadership & Equipment Management Primary maintenance coordinator for critical infrastructure across multiple facilities, maintaining operational excellence for specialized equipment including walk-in freezers (-20°C), ultra-low temperature systems (-80°C), cryogenic LN2 systems, and integrated alarm/surveillance networks. 10+ years’ experience in the operation, troubleshooting and maintenance of analytical instrumentation (GC, GC/MS, HPLC) ensuring continuous quality operations. Technology Transfer & Process Innovation • Established international biorepository operations in Ukraine with complete technology transfer • Developed automated inventory systems reducing regulatory reporting from months to hours • Directed construction of 3,700 ft² specialized research drug processing facilities Regulatory Excellence GxP Operations & Regulatory Compliance (FDA, DEA), FDA 21 CFR Part 11 compliance, GxP systems validation, controlled substances management (DEA), environmental monitoring (EPA), and quality assurance programs maintaining continuous regulatory compliance. Core Competencies: Manufacturing Operations | Controlled Substances & Pharmaceutical Repository Management | Biologics Processing | Aseptic Processing | Technology Transfer | Equipment Maintenance | Cross-Functional Leadership | Process Optimization | Regulatory Compliance I am available for new opportunities and would enjoy talking to you if you feel that my qualifications match your needs.