Alliyah Argiro
Mount Laurel,NJ
Summary
Responsive Manufacturing Technician with highly developed skills in downstream processing and GDP and GMP. Sound knowledge of production operations. Well-versed in streamlining and optimizing processes to exceed expectations.
Overview
2
2
years of professional experience
Work History
Aseptic Manufacturing Technician II
Iovance Biotherapeutics
06.2023 - Current
- Provide operational support, including materials stocking, kit and reagent preparation, cleaning, and equipment maintenance
- Contributed to technology transfer, coordinated front-end document requests, and ensured prompt initiation and completion of tasks
- Adhere to GMP and SOPs, including Good Documentation Practices (GDP)
- Improving Manufacturing Efficiency: collaborating with cross-functional teams to update and refine SOP’s, thereby streamlined manufacturing processes, enhanced compliance with GMP standards, and reduced occurrence of deviations
- Proficient in LabVantage Laboratory Information Management Systems (LIMS), manufacturing execution system (MES), Sales Force, and MasterControl
- Conducted source data verification of master batch records
- Record data to meet regulatory requirements and assist in drafting, editing, and approving SOPs, Batch Records, Deviations, and CAPAs
- Performed in-house audits and reviewed logbooks across all grade levels (D, C, B, A)
- Work collaboratively and independently, following written procedures and recognizing deviations from accepted practices.
Manufacturing Associate
WuXi AppTec
06.2022 - 04.2023
- Led manufacturing processes and managed equipment and documentation change controls
- Utilized technical writing skills to produce, revise, and edit batch records and SOPs, and developed client-specific training programs
- Participated in process development for new projects and managed deviations and CAPA investigations
- Conducted purification processing, including Clarification, Tangential Flow Filtration (TFF), and chromatography
- Operated lab equipment, including Nucleocounter-200, Vicell BLU, LOVO, Gatherex, Nucleofection, CliniMacs, and BacT
- Used support systems such as LIMS and Blue Mountain RAM.
Education
Bachelor of Science in Biology -
Rowan University
Glassboro, NJ07.2021
Associate of Science in Pre-veterinary Studies -
Rowan College of South Jersey
Sewell, NJ12.2019
Skills
- Aseptic Technique
- Good Manufacturing Practice (GMP)
- Tangential Flow Filtration (TFF)
- Ultra/Diafiltration
- High-Performance Liquid Chromatography (HPLC)
- Batch Records
- Sample Preparation
- Biotechnology
- Pharmaceutical Industry
- SOP Editing
- Safety Protocols
- Good Manufacturing Practices
- Equipment Troubleshooting
- Precision Assembly
- Adaptive Problem Solving
- OSHA Compliance
- Process Improvement
- Safety operation procedures
- Staff Training
- Welding Techniques
Relevant Expertise
- Proficient in manufacturing cell and gene therapy products using suspension and adherent processes.
- Experienced in cell banking, viral vector production, and cell therapy manufacturing with a focus on upstream and downstream operations.
- Proficient understanding of ICH GCP and FDA 21 CFR regulations, encompassing Parts 11, 50, 58, and 601.
- Skilled in ALCOA-C clinical trial documentation practices with a thorough comprehension of Patient rights and Informed Consent Processes.
- Skilled in comprehending and ensuring compliance with clinical protocols.
- Experience in revising SOPs and implementing deviation request reports to improve operational efficiency and ensure compliance.
- Acquired hands-on experience in a veterinary clinic, including appointment scheduling and medical communication.
- Skilled in Microsoft Office, Excel, Good Manufacturing Practices (GMP), and editing Standard Operating Procedures (SOPs).
Timeline
Aseptic Manufacturing Technician II
Iovance Biotherapeutics
06.2023 - Current
Manufacturing Associate
WuXi AppTec
06.2022 - 04.2023
Bachelor of Science in Biology -
Rowan University
Associate of Science in Pre-veterinary Studies -
Rowan College of South Jersey
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