Process Engineer Cell Therapy
Resume:
Fatjona Zemanaj
Collaborative and detail-oriented Senior Process Engineer with 5+ years of experience in cell therapy manufacturing. Dedicated to delivering high quality work for continuous achievement of company goals and betterment of patients’ lives.
Experience
December
2023 - Present
March 2022 –
December
2023
December
2021 – March
2022
May 2020 –
December
2021
January 2020
- May 2020
April 2019 –
January 2020
Adaptimmune Therapeutics, Philadelphia, PA
Senior Process Engineer
• Acted as SME during FDA Pre-License Inspection and streamlined all technical documentation through commercialization of TECELRA
• Site lead for media fill program; including cross-functional coordination of execution and APS continuous improvement
• Manage change controls and coordinate completion of action items across Manufacturing, Quality, Supply Chain, and Validation teams
• Lead MS&T team in execution of validation studies using GxP, generation of summary reports
Process Engineer
• MS&T point of contact for upstream and downstream knowledge for impact and risk assessments
• Assisted in development of closed-system Harvest process (planning and execution of test runs, data analysis)
• Revised MBRs, process specifications, and control strategy documents, and reviewed BLA submission documents
Senior Manufacturing Cell Therapy Specialist
• Manufacturing SME, and led in troubleshooting, personnel training, and document revision of clinical processes
• Assisted in preparation for PPQ readiness and BLA filing
• Led technology transfer of NC-3000 Image Cytometer and associated method into manufacturing area; managed timelines and change control, oversaw validations, procured raw materials, and trained personnel
Manufacturing Cell Therapy Specialist
• Manufactured autologous T-cell therapy DP for 3x clinical processes
• SME on all manufacturing operations, media preparation, and equipment operation
• Safely handled blood-based intermediates, DP, and lentiviral vector
• Assisted in investigation of deviations, RCA’s, and CAPAs
• Authored and reviewed SOPs, batch records, logbooks, and other MFG
& Quality documents per process improvements
WuXi Advanced Therapies Philadelphia, PA
Manufacturing Associate II
• Collaborated with client in technology transfer of new process, including equipment procurement and qualification, suite layout, and material procurement
• Authored and revised GMP batch records, SOPs, and other quality documents
• Organized a dynamic inventory of raw materials and drug product, and coordinated client-requested shipments regularly
• Identified areas of improvement and deviations, and offered suggestions for CAPAs and SOP revisions
Manufacturing Associate I
• Aseptically manufactured PMBC’s and allogeneic CAR T cell therapy drug products
• Ensured GMP and GDP compliance and audit readiness Philadelphia, PA
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Education
B.S. Biological Sciences
Drexel University
Philadelphia, PA
Skills
Technical writing
Problem Solving
Effective communication
Project management
Knowledge
Aseptic Technique, Cell Washing
/ Concentration, Cell Counting,
Vector Transduction,
Transfection, Cell Activation,
Bioreactor inoculation, Cell
Harvesting, Final Drug Product
Formulation and Fill, Equipment
Troubleshooting, PPQ / BLA
Equipment
Xuri W25 Bioreactor
G-Rex Bioreactor
BSC
Cue
Sepax
Plasmatherm & Cytotherm
Sterile Tube Welder & Sealer
Gatherex Pump
CTS DynaMag
CliniMACS Prodigy
ViCell XR
NC-200
NC-3000
AgilePulse Transfection System
MaxCyte
Centrifuge
Crystal M1 Filler
Filter Integrity Tester
Autoclave
LN2 & CRF
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