Leslie Melvin
Four Oaks,NC
Summary
Results-driven bioprocess professional with expertise from FUJIFILM BIOTECHNOLOGIES, specializing in cGMP compliance and process optimization. Proven track record in enhancing batch quality and throughput through effective data analysis and teamwork. Certified in column packing, I excel in maintaining equipment standards and ensuring regulatory adherence while leading cross-functional teams.
Overview
1
1
Certification
8
8
years of professional experience
Work History
MANUFACTURING ASSOCIATES III
FUJIFILM BIOTECHNOLOGIES
02.2022 - Current
- Operated and optimized bioprocess equipment in cGMP setting, ensuring high batch quality and timely throughput.
- Managed TFF concentration and buffer exchange as a UF/DF certified operator, enhancing right-first-time batches.
- Optimized CPPs by adjusting TMP flux and in-process controls, achieving target purity and yield.
- Executed end-to-end upstream and downstream operations, including mammalian cell culture and microbial fermentation.
- Certified in column packing and purification; conducted HETP qualification to monitor separation efficiency.
- Performed nanofiltration for small-molecule clearance, controlling CPPs to meet specifications.
- Executed clean-in-place and steam-in-place processes to maintain equipment sanitation standards.
- Conducted identity checks and returns through PAS-X, ensuring compliance with protocols.
IGIV-C TECHNICIAN
GRIFOLS BIOTHERAPEUTICS
10.2018 - 02.2022
- Fully cross-trained across end-to-end downstream operations for 10% IVIG, including membrane press filtration, caprylate treatment, plate/frame filtration, chromatography column and skid operation, column regeneration, pre-equilibration/equilibration, ultrafiltration, diafiltration, transfer to formulation, and nanofiltration.
- Recognized subject-matter expert from initial plasma suspension through final concentrated sterile product.
- Operated and monitored automated chromatography skids and process controls; maintained parameters within defined ranges and escalated deviations per SOP.
- Executed clean-in-place and steam-in-place procedures to ensure equipment cleanliness and compliance with safety standards, changeovers, and column packing/regeneration to ensure equipment readiness and batch right-first-time.
- Troubleshot process and equipment issues, conducted root-cause analysis, and implemented corrective actions to restore throughput and ensure regulatory compliance.
- Performed cGMP and EHS audits of production areas, documented findings, and coordinated remediation efforts to address compliance gaps.
PACKAGING LINE INSPECTOR/LABEL VERIFICATION TECHNICIAN
GRIFOLS BIOTHERAPEUTICS
10.2018 - 02.2022
- Led team of 10+ personnel to inspect, label, and package 800,000 vials during two-week shutdown.
- Set up and troubleshot labeling machines, optimizing production processes for maximum efficiency.
- Documented job tasks in batch production records and standard operating procedures, ensuring compliance and operational consistency.
- Served as primary trainer for new employees, providing guidance on processes and policies. to enhance skill development within six months.
Education
B.S. - Industrial Distribution and Logistics
East Carolina University
Greenville, NC12-2028
A.S. -
Johnston Community College
Smithfield, NC01-2018
Skills
- cGMP compliance
- PAS-X expertise
- Column packing certification
- Process optimization
- Quality assurance oversight
- Data analysis proficiency
- Processing suites leadership
- Process documentation management
- Equipment upkeep proficiency
- 5S application
- HACCP participation
- Environmental compliance assurance
- Safety protocol adherence
- Communication and teamwork
Certification
BioWork Process Technician Certificate (2017); Phlebotomy Certification (2014)
Timeline
MANUFACTURING ASSOCIATES III
FUJIFILM BIOTECHNOLOGIES
02.2022 - Current
IGIV-C TECHNICIAN
GRIFOLS BIOTHERAPEUTICS
10.2018 - 02.2022
PACKAGING LINE INSPECTOR/LABEL VERIFICATION TECHNICIAN
GRIFOLS BIOTHERAPEUTICS
10.2018 - 02.2022
B.S. - Industrial Distribution and Logistics
East Carolina University
A.S. -
Johnston Community College