Andie Koko

Beyond the typical manufacturing role, it's about leading in the absence of the area manager, setting the standard for excellence, and guiding a team toward the successful production of vital gene therapies. With your deep understanding of GMP and hands-on experience with virus production,

• Provide guidance, training, and support to junior staff to ensure the team's success.
• Ensure the timely setup of equipment and materials for each production run.
• Plan and prepare all necessary resources for various processes and activities.
• Assist in other production areas as needed.
• Demonstrate exceptional aseptic technique with precise, deliberate movements.
• Oversee and execute the manufacturing process of viral vector production, including cell culture, transfection, as well as virus purification techniques such as chromatography, tangential flow filtration, and formulation.
• Conduct analytical tests such as cell density, metabolites, osmolality, pH, and conductivity.
• Demonstrate proficiency while operating single-use bioreactors.
• Troubleshoot equipment and processes in partnership with the Manufacturing Science and Technology department.
• Maintain the cleanliness and appearance of cleanroom facilities and equipment.
• Maintain raw material inventory levels.
• Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements through the manufacturing process.
• Maintain accurate and detailed documentation of manufacturing activities, including batch records, production records, and quality control data.
• Ensure all records are complete, per regulatory guidelines.
• Demonstrate initiative to revise and initiate Batch Production Records, Standard Operating Procedures, study protocols, and reports.
• Lead independent projects as assigned, contributing to the overall success of the manufacturing team.
• Prepare media and buffer solutions that are critical for production processes.
• Promote a culture of safety and compliance within the manufacturing facility.
• Ensure all manufacturing activities are conducted per Standard Operating Procedures.
• Collaborate with cross-functional teams, including Process Development, Manufacturing Science and Technology, Quality Control, Quality Assurance, and Supply Chain, to support the successful execution of manufacturing campaigns and project timelines.
• Adjust machine settings according to product specifications or process changes.
• Participated in regular meetings with supervisors and other personnel to discuss progress and potential improvements on current projects.
• Collaborate with other team members to enhance production processes while ensuring that safety protocols are consistently followed.
• Collaborated closely with other departments to ensure thetimely completion of projects.
• Followed established manufacturing guidelines related to quality assurance standards.

• Company Overview: Piper Companies Contractor
• Operated within Clinical Biologics all-stream manufacturing (MFG) cleanroom spaces, providing critical on-site support for biologic production processes.
• Demonstrated proficiency in cell culture operations, including work within biosafety cabinets, performing bioreactor operations (e.g., tabletop and single-use bioreactors), and executing centrifuge harvests for cell separations.
• Contributed to media and buffer preparation by executing precise raw material weigh-outs and ensuring compliance with specifications for biological processes.
• Supported downstream purification processes using AKTAready chromatography systems to assist in protein purification for clinical use.
• Performed basic analytical testing, including protein concentration, pH, and osmolarity to monitor cell culture and downstream production quality.
• Assisted with manual cleaning (CIP) and autoclaving of materials and equipment, ensuring adherence to GMP (Good Manufacturing Practices) and sterile conditions.
• Conducted cell culture techniques, including cell counts, splitting, and other processes to maintain optimal cell growth and productivity.
• Played a key role in team coordination and support, demonstrating both leadership and collaboration in a fast-paced, cross-functional environment.
• Utilized SAP for materials consumption tracking and DLIMS (Laboratory Data Information Management System) for accurate sample submissions.
• Packaged and coordinated sample transport for analysis, ensuring safe handling and compliance with regulatory standards.
• Communicated effectively both verbally and in writing, with team members and cross-functional stakeholders, to ensure smooth operations and project alignment.
• Piper Companies Contractor

• Spearheaded operational scheduling and chaired Production Planning meetings, ensuring smooth coordination of workflows to meet production targets.
• Led the optimization of cell culture processes for cell lines, including CHO, HEK293, and Vero cells, focusing on maximizing cell growth in adherent cultures.
• Conducted on-the-floor process mapping to streamline large-scale production, ensuring adherence to regulatory compliance and cGMP guidelines.
• Drafted Phase 1 clinical batch records, SOPs, and technical reports, ensuring accurate documentation of process details and improvements.
• Played a key role in troubleshooting equipment, initiating CAPAs, and implementing process improvements that reduced production downtime.
• Actively contributed to the development and improvement of raw materials and media, ensuring consistent and high-quality production.

• Utilized automated equipment for cell processing and expansion, with a focus on T-cell line therapies and viral vector production.
• Worked with patient-derived blood and adhered strictly to cGMP standards, including aseptic techniques in cleanroom spaces.
• Led training sessions and continuously improved SOPs and inventory management protocols using Excel and SharePoint.
• Performed environmental monitoring, viable and non-viable sampling, and personnel monitoring to ensure compliance with safety and quality standards.

• Managed the optimization of upstream cell culture processes for CHO mammalian cell lines, focusing on media, feed, and buffer variations.
• Oversaw bioreactor operations (500L) and maintained cGMP practices during process operations, including cell thawing, splitting, and harvesting.
• Ensured proper documentation and record-keeping in LIMs and SAP systems, supporting smooth production and regulatory compliance.
• Reviewed and revised batch records, SOPs, and CAPA plans, leading process optimization initiatives that improved productivity and efficiency.