OPEYEMI OGUNYANKIN
Houston,TX
Summary
Dedicated and detail-oriented professional with a strong background in manufacturing cellular products within cGMP facilities. Seeking a challenging position where I can utilize my expertise in adhering to SOPs, aseptic techniques, and ensuring compliance with regulatory standards.
Overview
6
6
years of professional experience
1
1
Certification
Work History
VIRAL VECTOR SPECIALIST
Lonza Biologics Inc.
Pearland, TX
05.2021 - Current
- Engage in the manufacturing of cellular products with minimal supervision, following established SOPs within a cGMP facility.
- Adhere to aseptic techniques throughout the processing stages to uphold the integrity, viability, and sterility of cellular products until the final product (Bulk Lentiviral Vector-BLV) is packaged.
- Carry out preparations of Growth Media and Buffers, including sample collection for Quality Control testing.
- Ensure team activities comply with processes, procedures, and instructions, following Work Instructions and promptly identifying any deviations from accepted practices.
- Utilize NC-200 for cell counts, ensuring accurate calculations for infusion cell doses, viabilities, dilutions, and cell concentrations with zero errors.
- Assist in maintaining precise documentation in adherence to FDA regulations, encompassing GLP, GMP, and GDP.
- Operate manual, semi-automated, and automated equipment (Centrifuge, Incubators, PH Meter, Rocker, Scales, Pumps, Torque Tester, etc.) for routine clinical production, including using environmental monitoring equipment such as Solairs, ApexZ50, and Active Counters.
- Contribute to the editing and reviewing of SOPs and batch records, actively maintain and restock the clean room environment with released inventory, and monitor temperatures, material expirations, and calibrated equipment.
- Utilize SAP Software for Goods movements and Material consumptions.
- Conduct In-process Filter Integrity Testing.
Production Associate
Quva Pharma Inc,
Sugar Land, TX
08.2020 - 05.2021
- Conducted line and room clearances in accordance with established procedures.
- Assisted in inspecting, labeling, and processing of production materials such as IV Bags, syringes etc.
- Ensured all necessary documentations are completed.
- Notified production management of any deviations from established processes or procedures
Operation Technician II
Alcon
Houston, TX
09.2018 - 08.2020
- Assisted in building and assembling Cassettes for eye surgeries.
- Packed-off surgical eye products into trays and work at a fast pace.
- As a machine Operator, ensured that all products have the required label and conforming with standard operating procedures.
- Completed documentation of activities in accordance to established procedures and performing line clearance when due.
- Followed production and safety procedures.
- Maintained good documentation practice and smooth flow of production.
Education
LLB - Management
University of Ado-Ekiti
Ado-Ekiti06-2007
High School Diploma -
Holy Trinity Grammar School
Ondo08-2001
Skills
- Aseptic Technique
- Documentation Compliance
- Technical Cell Manipulation
- Environmental Monitoring
- Compliance with FDA regulations, GLP and GMP
- Calculation Accuracy
- SOP and Batch Record Editing
- Equipment Operation
- Inventory Management
- Team Collaboration
Certification
Pharmacy Technician Certification (2020)
ACPE Sterile products Certification (2020)
National Sterile Compounding Training:
· Express appropriate formulations and methods for the calculation of various sterile compounded preparations.
· The 3 Risk levels used in sterile compounding and the compounding, storage, and cleaning requirements for each risk level.
· Aseptic hand washing.
· Proper gowning and sterile gloving
· Vertical and Horizontal hood cleaning technique
· Proper powder vial reconstitution technique
· Liquid vial and ampule compounding technique
Timeline
VIRAL VECTOR SPECIALIST
Lonza Biologics Inc.
05.2021 - Current
Production Associate
Quva Pharma Inc,
08.2020 - 05.2021
Operation Technician II
Alcon
09.2018 - 08.2020
LLB - Management
University of Ado-Ekiti
High School Diploma -
Holy Trinity Grammar School
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