Kelvin Asante
Frederick
Summary
Versatile biopharmaceutical and IT professional with hands-on experience in GMP environments, ensuring regulatory compliance and operational efficiency. Expertise in process optimization, batch record management, and troubleshooting technical issues in laboratory settings. Collaborative team player adept at maintaining quality and safety standards in fast-paced environments.
Overview
1
1
Certification
13
13
years of professional experience
Work History
GMP Specialist
ABL (Advanced Bioscience Laboratories)
Rockville
11.2024 - Current
- Operated GMP grade manufacturing equipment, including autoclaves, analytical balances, pH/conductivity meters, and biosafety cabinets, within classified cleanroom environments to ensure compliance with regulatory standards.
- Maintained detailed and accurate batch production records and SOPs, ensuring full compliance with FDA and internal quality standards.
- Reviewed GMP documentation and conducted data integrity checks to support successful audits, investigations, and implementation of continuous improvements.
- Troubleshot process deviations, equipment malfunctions, and non-conformances, ensuring rapid resolution and adherence to compliance requirements.
- Performed upstream production activities including cell culture preparations, operation of bioreactors, incubators, and analytical equipment following established cGMP protocols.
- Conducted in process sampling, aseptic manipulations, and equipment sterilizations in accordance with Biosafety level 2 standards.
- Participated in cleanroom maintenance, gowning procedures, and environmental monitoring to uphold sterility assurance levels in production areas.
Cell Therapy Specialist
Kite Pharma
Urbana
11.2022 - 10.2024
- Genetically modified patient’s T-cells in a GMP environment to produce cellular therapy products.
- Tested and verified the quality, purity, and potency of cellular therapy products.
- Ensured the safety and quality of the cellular therapies being manufactured.
- Maintained comprehensive documentation of batch records, standard operating procedures, and quality control data to ensure compliance and traceability.
- Documented all manufacturing activities accurately and completely in compliance with regulatory requirements.
- Adhered to safety protocols and regulations, including handling of hazardous materials, waste disposal, and maintenance of clean room environments.
- Operated and monitored BSC and other equipment during manufacturing, ensuring proper cleaning and functionality to maintain safety standards.
- Troubleshot technical issues, investigated deviations, and identified solutions to enhance manufacturing processes of cellular therapy products.
- Participated in ongoing training and development activities to stay current with industry trends, best practices, and regulatory requirements.
- Utilized Pas-X and EBS systems for managing production processes.
Verification Representative
Music and Arts (Corporate Office)
Frederick
09.2019 - 12.2022
- Verified customer information for accuracy and currency.
- Conducted bank verification for orders exceeding one thousand dollars to mitigate fraud risk.
- Processed customer orders, including verifying payment details and updating customer records.
- Assisted manager with paymode and payment processing to ensure timely transactions.
- Resolved customer issues and complaints efficiently.
- Collaborated with other departments to resolve issues related to orders, payments, and customer service.
- Delivered excellent customer service while maintaining a positive and professional demeanor in all interactions.
- Performed data entry by accurately inputting customer information into the database.
- Including Checking customer orders, contact details, and billing information.
Manufacturing Technician
AstraZeneca
Frederick
01.2022 - 11.2022
- Operated and maintained manufacturing equipment, such as Bioreactors, Centrifuges, and Filtration systems.
- Operated and maintained manufacturing equipment according to the Standard Operating Procedures (SOPs).
- Prepared and cleaned equipment to ensure readiness and reliability for the next production run.
- Conducted quality control tests on raw materials and finished products to confirm compliance with quality standards.
- Followed Good Manufacturing Practices (GMP) and regulatory guidelines to ensure compliance with quality and safety standards.
- Maintained accurate records of production processes, equipment maintenance, and quality control tests to support operational efficiency.
Desktop Support Specialist
Infinity Consulting Solutions
Hagerstown
04.2017 - 09.2019
- Supported end users by resolving software and hardware problems, ensuring uninterrupted workflow throughout the organization.
- Installed applications in client environments, troubleshot issues, backed up data, and upgraded systems to enhance user functionality.
- Troubleshoot TCP/IP networking issues, make sure PCs/Laptops and peripherals function properly.
- Physical decommission and installation of desktops, peripherals, monitors, monitor arms, docking station, monitor, keyboard, mouse and printer.
- Maintained and created a document management system to safeguard data and streamline restoration processes.
- Perform troubleshooting/problem resolutions on Wide Area Network (WAN) issues.
- Executed risk assessments and evaluated risks to the business and develop risk mitigation strategies.
- Worked with various types of network infrastructure tools and equipment such as Cisco, Juniper, and Forerunner, and leveraged network analysis.
- Work with members of SaaS development, cloud services, services and operations teams to incorporate applicable industry regulatory standards.
- Tools such as Cisco Prime, SolarWinds, Identity Services Engine, Cisco Adaptive Security Device Manager, Science Logic SL1, etc.
Pharmacy Technician
CVS Pharmacy
Frederick
01.2014 - 03.2017
- Filled and labeled prescriptions by accurately counting pills and measuring liquids for efficient medication packaging.
- Entered patient and prescription information into pharmacy’s computer system.
- Assisted pharmacist with daily pharmacy operations, facilitating smooth workflow and enhancing service delivery.
- Compounded medications, such as creating custom medications based on a doctor’s prescription.
- Assisted with inventory management by ordering and receiving medication shipments and stocking shelves while organizing proper storage of medications.
- Delivered customer service to patients by answering phone calls, addressing questions, and guiding on over-the-counter medications to ensure informed choices.
Education
M.S. - Cyber Technology
University of Maryland, Global Campus
Adelphi, MD08-2027
Skills
- GMP Compliance
- Process Validation
- Quality Assurance
- Documentation control
- Batch Record Management
- Cleanroom Protocols
- Sterility Assurance
- Protocol compliance
- Process Optimization
- Production Efficiency
- Laboratory Procedures
- Equipment Maintenance
- Troubleshooting Techniques
- Risk Management
- Safety Protocols
- Regulatory Standards
- Training programs
Certification
CompTIA Security + CE
Timeline
GMP Specialist
ABL (Advanced Bioscience Laboratories)
11.2024 - Current
Cell Therapy Specialist
Kite Pharma
11.2022 - 10.2024
Manufacturing Technician
AstraZeneca
01.2022 - 11.2022
Verification Representative
Music and Arts (Corporate Office)
09.2019 - 12.2022
Desktop Support Specialist
Infinity Consulting Solutions
04.2017 - 09.2019
Pharmacy Technician
CVS Pharmacy
01.2014 - 03.2017
M.S. - Cyber Technology
University of Maryland, Global Campus