Frank Koza
- Role
- Mst Manager - Viral Vector Services at ThermoFisher Scientific
- Location
- Derry, NH, US
- LinkedIn followers
- 500 followers
About Frank Koza
I am a seasoned biotechnology professional with experience in manufacturing operations…
Experience
Mst Manager - Viral Vector Services
Oct 2020 — Present
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 environment delivering viral vector based gene therapy processes and products. • 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 action items. • Coordinate support of multiple client programs while providing growth and career development upstream MST team through resource allocation, training, job shadowing and mentoring.
Skills
- Process Simulation
- Six Sigma
- Software Documentation
- Clinical Development
- Biotechnology
- Filtration
- V&V
- Cross-Functional Team Leadership
- Trackwise
- Aseptic Processing
- Manufacturing
- Capa
- Corrective and Preventive Action (Capa)
- Technology Transfer
- Gmp
- Biopharmaceuticals
- Quality System
- Validation
- Change Control
- Purification
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