Alliyah Argiro
Bordentown,NJ
Summary
Accomplished Senior Aseptic Manufacturing Technician with a proven track record at Iovance Biotherapeutics, specializing in Gen 2 process optimization and deviation reduction. Expert in GMP and SOP compliance, adept at cross-functional collaboration to enhance manufacturing efficiency. Skilled in aseptic technique, demonstrating exceptional technical writing and problem-solving abilities.
Overview
3
3
years of professional experience
Work History
Senior Aseptic Manufacturing Technician
Iovance Biotherapeutics
Philadelphia, PA
06.2023 - Current
- Expert in Gen 2 process, consistently reducing deviation generation and enhancing processing efficiency
- Initiate and submit deviations, ensuring thorough documentation and compliance to improve quality control
- Actively contribute to optimizing workflows, ensuring smooth operations on the production floor
- Skilled in managing and observing area operations, ensuring adherence to process standards and safety protocols
- Collaborated with cross-functional teams to update and refine SOPs, improving manufacturing efficiency, streamlining processes, and reducing deviations
- Adhere to GMP and SOPs, including Good Documentation Practices (GDP)
- Proficient in LabVantage LIMS, manufacturing execution systems (MES), Salesforce, and MasterControl
- Perform source data verification for master batch records and ensure compliance with regulatory requirements
- Conduct in-house audits and review logbooks
- Work collaboratively and independently, adhering to written procedures and identifying deviations from accepted practices
- Provide operational support in materials stocking, kit/reagent preparation, equipment maintenance, and cleaning
- Contributed to technology transfer, managing document requests, and ensuring timely initiation and completion of tasks
Manufacturing Associate
WuXi AppTec
Philadelphia, PA
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, SOPs, and client-specific training programs
- Participated in process development for new projects, managed deviations, and conducted CAPA investigations
- Conducted purification processing, including Clarification, Tangential Flow Filtration (TFF), and chromatography
- Operated lab equipment such as Nucleocounter-200, Vicell BLU, LOVO, Gatherex, Nucleofection, CliniMacs, and BacT
- Utilized support systems like LIMS and Blue Mountain RAM for operational efficiency
Education
Bachelor of Science - Biology
Rowan University
Glassboro, NJ07.2021
Associate of Science - Pre-veterinary Studies
Rowan College of South Jersey
Sewell, NJ12.2019
Skills
- Aseptic Technique
- Deviation Initiation
- Good Manufacturing Practices (GMP)
- Tangential Flow Filtration (TFF)
- Ultra/Diafiltration
- High-Performance Liquid Chromatography (HPLC)
- Batch Records
- Sample Preparation
- Biotechnology
- Pharmaceutical Industry Expertise
- SOP Editing and Compliance
Relevant Expertise
- Proficient in manufacturing cell and gene therapy products using both suspension and adherent processes.
- Experienced in cell banking, viral vector production, and cell therapy manufacturing, specializing in upstream and downstream operations.
- Comprehensive knowledge of ICH GCP and FDA 21 CFR regulations, including Parts 11, 50, 58, and 601.
- Skilled in ALCOA-C clinical trial documentation practices, with a focus on patient rights and informed consent processes.
- Strong understanding of clinical protocol compliance and ensuring operational adherence.
- Expertise in revising SOPs and implementing deviation request reports to enhance operational efficiency and compliance.
- Proficient in Microsoft Office, Excel, Good Manufacturing Practices (GMP), and SOP editing.
Timeline
Senior Aseptic Manufacturing Technician
Iovance Biotherapeutics
06.2023 - Current
Manufacturing Associate
WuXi AppTec
06.2022 - 04.2023
Bachelor of Science - Biology
Rowan University
Associate of Science - Pre-veterinary Studies
Rowan College of South Jersey
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