Sixtus Nnawuba
Wilmington
Summary
An innovative and dedicated Chemical Engineer with over 5 years of experience leading aseptic manufacturing processes, driving revenue growth through biotechnology and FDA regulations expertise. I am skilled in optimizing cell viability, managing equipment operations, and ensuring compliance with industry standards. Proven track record in enhancing operational efficiency, quality control, and project management. Seeking to leverage technical acumen and collaborative skills to drive manufacturing excellence and project success.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Lead Biotech upstream and Downstream Process
Iovance Biotherapeutics Inc.
Philadelphia, Pennsylvania
10.2023 - Current
- Drove the commercialization of AMTAGVI for advanced Melanoma at Wuxi Advanced Therapy, resulting in a 30% revenue upswing by harnessing expertise in biotechnology, particularly in cell therapy, and applying an in-depth understanding of FDA regulations for the groundbreaking skin cancer treatment globally.
- Reviewed Batch Records and Log reconciliations using SAP and Excel, improving accuracy.
- Streamlined logbook and label creation process, improving efficiency with a production volume.
- Applied sterile handling techniques to collect and preserve tumors in a biosafety cabinet and incubator, resulting in heightened sample viability for testing and increased accuracy of experimental outcomes, thus minimizing errors and ensuring consistent findings.
- Reduced contamination risk, increased cell purity, and enhanced efficiency by using a Lovo Machine for cell filtration and washing in conjunction with PCR cell culture techniques.
- Performed major manipulations using a repeater pipette, micro pipette, and pipette aid, showcasing precision handling skills.
- Utilized plasma thawing equipment to execute the feeder cell deforestation process, increasing cell quality and operational efficiency per batch.
- Conducted cell counting using the Nucleocounter NC-200 machine with ImageJ and Excel, ensuring enhanced data reliability and increased sample viability for testing using sterile handling techniques.
- Showcased technical expertise in equipment operation, performing scheduled equipment checks, and carrying out calibration and troubleshooting tasks for Sealer, Balance, Welder, Centrifuge, Baxa Repeater Pump, and water bath to enhance output quality and streamline operations processing manipulations.
- Utilized the Controlled Rate Freezer (CRF) for cryotube and bag freezing, ensuring sample integrity, boosting efficiency, and enhancing the preservation process alongside cryopreservation equipment.
- Managed final product storage in the Liquid Nitrogen Freezer (LN2) with a capacity for 1000+ samples, overseeing sample labeling, temperature monitoring, and inventory management processes.
- I am a certified trainer in Wuxi Advanced Therapies on processing equipment, such as the NC-200, Lovo, Centrifuge, Water bath, Plasmatherm, Pumpmatic, welder, sealer, controlled-rate freezer (CRF), Liquid Nitrogen Tank (LN2), and 80 C Freezer.
Quality Control Specialist
Integra Life Sciences
Plainsboro Township, New Jersey
06.2022 - 02.2023
- Ensure compliance with all company policies, procedures, and appropriate regulations, including FDA and ISO 9001, ISO 13485, CMDR, and the Medical Device Directive.
- Enhanced operational efficiency by analyzing compound structures using HPLC and UPLC instruments.
- Implemented quality control tools to institute equipment and test standard procedures in alignment with ISO standards.
- Establish and implement equipment and test standard procedures.
- Established protocols for biohazard material disposal in alignment with OSHA standard operating procedures, leading to a decrease in contamination risks.
- Employed a centrifuge to segregate biochemical samples into solid and liquid components, and expedited sample analysis with MATLAB and Excel integration.
- Instituted procedures for disposing of biohazard materials in compliance with OSHA standard operating procedures.
- Researched and implemented ultraviolet-based techniques for bacteria culturing, drug identification, and nucleic acid quality control, leveraging Fluorescence microscopy for advanced bacterial culturing methodologies and employing Sanger sequencing for nucleic acid quality control.
Lead Manufacturing Specialist
Cellularity
Florham Park, New Jersey
09.2020 - 05.2022
- Managed cell culture reagents and media. Established an ongoing supply of donor cell stock and master cell banks.
- Maintained laboratory equipment and managed clean rooms.
- Used a bioreactor for the upstream process cell line.
- Developed project process flow, training activities, and technical process transfers for existing and future products, using the SAP system, CMS, and Microsoft Excel.
- Implemented protocols to support manufacturing operations and deliver daily technical updates utilizing inventory management systems.
- Optimized workflow efficiency by managing the process flow for tissue cell culture micropropagation using Bioreactor systems and sterile laboratory equipment such as incubators and laminar flow hoods.
- Leveraged Flow cytometry and HPLC for precise execution of cell counting, cell culture, and metabolite analysis, effectively pinpointing cell abnormalities such as abnormal growth cells, infected cells, and dead cells.
- Utilized Flow Cytometry technology to increase project efficiency and leveraged Centrifuges and Shakers to enhance data accuracy.
Education
Master’s in Business Administration - Project Management
Strayer University
12.2025
Bachelor of Engineering - Chemical Engineering
Federal University of Technology, Nigeria
10.2016
Skills
- SAP
- MES SYSTEM
- BMRAM SYSTEM
- IREN SYSTEM
- PROGRAMMABLE LOGIC CONTROL
- Project Management
- LIMS SYSTEM
- MASTER CONTROL SYSTEM
- MS POWER BI
- Microsoft Office Suite
- CELL CULTURE
- TISSUE CULTURE
- SPREADSHEET
Certification
- Personal Financial Management, Contracting Resource
- United States Army Schools & Centers Diploma, Basic Combat Training Course 750-BT
- FEMA Introduction to Incident Command System ICS-100 | Aug 2023
- FEMA Introduction to Incident Command System ICS-200 | Aug 2023
- Advanced Individual Training, United States Army Transportation School | June 2023
Languages
English
Full Professional
Interests
- Sustainable Tech Innovations
- Tech enthusiast, passionate about exploring the latest advancements and innovations
- Youth Development Programs
- Advocacy Campaigns
- I enjoy helping others and giving back to the community
Timeline
Lead Biotech upstream and Downstream Process
Iovance Biotherapeutics Inc.
10.2023 - Current
Quality Control Specialist
Integra Life Sciences
06.2022 - 02.2023
Lead Manufacturing Specialist
Cellularity
09.2020 - 05.2022
Bachelor of Engineering - Chemical Engineering
Federal University of Technology, Nigeria
Master’s in Business Administration - Project Management
Strayer University