Frank Koza Email & Phone Number

Derry, NH, US

Écublens, Vaud, CH

• Responsible for the management of a team of upstream process engineers overseeing the execution of tech transfer activities and well as process technical support of clinical and GMP manufacturing operations in a CDMO.
• Provide technical input and project/program management for key tech transfer deliverables to support client program timelines and milestones
• Provide routine on the floor support for all upstream critical operations including troubleshooting and product impact assessments for forward processing and lot release decisions
• Create data collection systems for routine, real time review of process performance to assess process health and support forward processing and/or continuous improvement activities.
• Direct interaction with client on tech transfer, process establishment activities, issue resolution and data review.
• Identify, own and drive the implementation of continuous process improvement project in collaboration with client. The incudes ownership and/or support quality systems such as change controls, CAPAs and associated.

Tokyo, JP

• Staffed and managed a multi-site production technical support team of 8 engineers responsible for the successful tech transfer, regulatory approval and ongoing technical support of biopharmaceutical process operations.
• Provided leadership at daily site governance tier meetings through ownership of KPIs, meeting facilitation and escalation up down of key issues impacting plant operations.
• Developed team functioning as first responders to “on the floor” process events. This team provided event containment guidance and forward processing justification in collaboration with quality and manufacturing.
• Provided technical support for on time quality system closure through generation of technical impact assessments, test protocols for investigations and feasibility data for deviations, CAPAs and change controls.
• Provided Process subject matter expertise and leadership for introduction of new processes into GMP manufacturing facility from clinical runs through process validation into GMP commercial operations.
• Set up of univariate/multivariate process monitoring program for critical operating and performance parameters as well as prospective detection of process events during manufacturing operations.

New York, New York, US

• Responsible for facilitating and executing the technology transfer of pre-clinical, clinical and commercial processes into a multi-product cGMP production facility.
• Coordinates the finalization and transfer of process specifications and associated tech transfer documentation from process development to receiving organizations.
• Executes site assessment activities to determine facility fit for new processes being transferred into existing facilities.
• Facilitates equipment, procedural and automation related change controls with cross functional disciplines to ensure readiness of facility, equipment and operations to receive and run new processes.

New York, New York, US

• Responsible for the planning and coordination of technology transfer and process validation activities between clinical and commercial phases of product lifecycle.
• Establish cross functional project core team and sub team structure for resolution of technical, regulatory and logistical issues impacting execution of project deliverables.
• Implement and track project schedule and gating criteria for presentation to senior project governance bodies at key milestone points.
• Define and author technology transfer and process validation master plans. Oversee generation and execution of process validation protocols.

Thousand Oaks, CA, US

• Responsible for the management of large scale protein purification manufacturing suite including column chromatography, UF/DF, viral filtration and bulk drug substance freeze unit operations. Specific responsibilities.
• Supervision and staff development of manufacturing team consisting of 5 direct and 24 indirect reports.
• Ensure established site and departmental target goals for downstream yield, recovery and success rate are met.
• Ensure adherence to cGMP compliance objectives – staff training, document review, timely closure of non-conformance investigations and CAPA closures and implementation of inspection readiness program.
• Lead continuous improvement projects such as second generation process implementation, success rate maximization, non-conformance reduction, run rate increase and cost of goods reduction.
• Key participant in regulatory agency inspections including facility walkthroughs, data review sessions with inspectors and ownership of audit observation responses.

Thousand Oaks, CA, US

• Area Manager for upstream Plant Engineering team responsible for the commissioning and on-going engineering/technical support of a 20K scale mammalian cell culture manufacturing facility.
• Developed, implemented and tracked start-up schedule for commissioning and qualification activities for upstream systems including bioreactors, harvest systems, media prep, protein purification and CIP systems.
• Hired and managed staff of 8 FTE Plant Engineers. Coordinated and executed integration of AR1 and AR5 Plant Engineering departments.
• Working with Capital Projects Engineering team, facilitated the mechanical completion and transfer of care, custody and control of process systems from general contractor prior to start of commissioning.
• Assigned as commissioning project team lead for all upstream systems. Led and facilitated regular start-up meetings, provided resolution of potential schedule impact issues and routinely tracked and updated project.
• Implemented and improved existing business systems for maintenance, spare parts, change control management, non-conformances and CAPAs for new facility.

Managed technical support group overseeing the operation of 1500L scale stirred tank perfusion based cell culture, primary recovery and protein purification suites.Led manufacturing project team for the design/build and start up of 1500L perfusion based cell culture/primary recovery and protein purification production suites.Provided technical transfer.