LINDEL PARKE
CAR-T manufacturing Associate with 4+ years in cGMP cleanrooms; skilled in cell culture,and EMES/EBR. Delivers on-schedule execution with right-first-time documentation and supports deviations assessments. Lean/5S and safety focused.
Work History
CAR-T Pharmaceutical Manufacturing Associate
4 Years 8 Months- Execute end-to-end CAR-T manufacturing processes including Abecma PBMC Isolation, Culture Initiation, Transduction, Cell Expansion and Drug Product Harvest and Breyanzi Transduction, Debead and Cell Expansion
- Completed GMP batch records, logbooks, and electronic documentation with emphasis on right-first-time execution.
- Identified and documented deviations, assisted in investigations, and contributed to root cause analysis and CAPA implementation.
- Collaborated with Quality Assurance, MSAT, and Supply Chain teams to facilitate on-time product release.
- Support in-process sampling, visual inspections, and material transfers in accordance with SOPs.
- Participate in routine equipment cleaning, sanitization, and preventive maintenance activities.
- Operated and maintained production equipment to ensure optimal performance and minimize downtime.
Package Handler
2 Years 1 Month- Successfully loaded trailers with freight weighing up to 400 pounds without incident or injury.
- Loaded and unloaded packages from trucks, ensuring timely delivery and adherence to schedules.
- Demonstrated ability to lift up to 75 pounds safely and repeatedly.
- Loaded trailers with freight weighing up to 400 pounds safely, contributing to incident-free operations.
- Operated various material handling equipment, enhancing efficiency in package handling processes.
- Operated material handling equipment to efficiently sort and transport packages.
- Collaborated with team members to ensure timely package processing and delivery.
Education
Bachelor of Business Administration - Accounting and Administrative & Information System
Skills
Accomplishments
Led the Abecma Suite 2 5S project in preparation for the PMDA inspection held August 18–21, supporting workplace organization, standardization, visual management, and overall inspection readiness.
Completed Lean White Belt Certification, strengthening my understanding of Lean principles and continuous improvement methodologies and applying these concepts to manufacturing operations.
Successfully completed cross-training across multiple Abecma and Breyanzi manufacturing processes, including Abecma PBMC Isolation, Culture Initiation, Transduction, Expansion, and Drug Product Harvest, as well as Breyanzi Transduction, Debead, Transduction, and Expansion.
Contributed to process improvement initiatives, including efforts to streamline the Abecma electronic batch record process with the objective of reducing unnecessary signatures, improving documentation efficiency, and maintaining compliance and data integrity.
Certification
Bloodborne Pathogen Certified, TWIC Certified
Languages
Personal Information
Title: ABECMA CAR-T MANUFACTURING ASSOCIATE