James Lee
Port Saint Lucie,FL
Summary
A Production Supervisor/Chemical Operator with experience in pharmaceutical manufacturing, troubleshooting and management of daily operations in a multi-ton API manufacturing site. Skilled Crew Chief motivates crew to drive improvements and maximize performance. Hands-on management professional adept at keeping employees operating at high standards of efficiency, accuracy and quality. Advanced maintenance leadership for around-the-clock maintenance of aircraft to maintain flight worthiness.
Overview
17
17
years of professional experience
Work History
Crew Chief/Chemical Plant Operator
AeroJet-General Corporation/AMPAC Fine Chemicals
Rancho Cordova, CA
02.1999 - 06.2016
- Managed log books to ensure timely data management and recording, as they apply to shift logs, tank and drum inspections, and environmental emissions records.liance with regulatory standards
- Utilized electronic waste management systems to oversee and ensure compliance for 90-day hazardous waste container tracking and reporting
- Served as a subject matter expert in Process Hazard Analyses (PHA), contributing to the identification, assessment, and mitigation of operational risks
- Supported the Department Manager in conducting investigations related to EH&S incidents and process deviations through structured root cause analysis
- Adhered to cGMP and GDP standards, ensuring precise and compliant documentation throughout all stages of active pharmaceutical ingredient (API) production
- Recognized as a subject matter expert in pharmaceutical manufacturing operations, including centrifuges, rotary and filter dryers, chemical reactors, distillation columns, SMB HPLC separation systems, and heat exchangers
- Directed daily production activities for a 30-member union workforce, managing assignments and ensuring adherence to safety, quality, and productivity goals
- Partnered with Process Engineers to align daily priorities and workflows with operational targets, maintaining performance metrics for cycle time and yield
- Prepared and submitted weekly departmental reports detailing personnel assignments, shift schedules, and staffing changes (e.g., vacation, sick leave)
- Participated in new process startups by executing installation and operational qualification (IQ/OQ) protocols in collaboration with engineering and validation teams
- Verified new equipment and manufacturing processes through execution and analysis of master batch records, ensuring consistent performance and compliance
- Conducted line tracing, process cleanings, and equipment qualifications using P&IDs, process flow diagrams, and mass balance documentation
- Mentored and coached union personnel; addressed performance issues through conflict resolution, corrective actions, and constructive feedback
Education
Environmental Education
NES
Folsom, CASkills
- Thorough understanding of state, county, and federal regulations governing pharmaceutical manufacturing compliance
- Proficient in interpreting piping and instrumentation diagrams (P&ID) and executing pharmaceutical batch records
- Extensive hands-on experience operating chemical process equipment, including reactors, dryers, mills, sieves, and pumps
- Skilled in handling hazardous materials, including carcinogens, cytotoxic agents, and flammable substances, with strict adherence to safety protocols
- Certified in Hazmat and HazWOPER procedures, ensuring safe and compliant operations
- Experienced in supervising large-scale pharmaceutical production processes and coordinating personnel across shifts
- Competent in executing GMP-compliant documentation, including batch records, installation and operational qualifications (IQ/OQ), and process validation protocols
- Adept at using control systems and HMI interfaces to monitor, trend, and optimize chemical manufacturing processes
Timeline
Crew Chief/Chemical Plant Operator
AeroJet-General Corporation/AMPAC Fine Chemicals
02.1999 - 06.2016
Environmental Education
NES
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