Doug Cubanski
- Role
- Manufacturing Sr Manager at AGC Biologics
- Location
- Golden, CO, US
- LinkedIn followers
- 500 followers
About Doug Cubanski
Biotechnology professional with extensive manufacturing and validation experience…
Experience
Manufacturing Sr Manager
Aug 2021 — Present
Managed all areas of GMP production with a team of 22 reports at a Gene Therapy and Cell Therapy manufacturing facility specializing in Viral Vector Gene Delivery • Experience with hiring, goal-setting, conflict resolution, performance reviews, termination, and compensation planning • Involved with all plant start-up activities including commissioning, IQ, OQ, PQ, implementation of a safety program and PPQ runs • Managed operation of seven Pall iCELLis bioreactors for upstream manufacturing • Managed operation of Cytiva XDR bioreactors for upstream suspension operations up to scale • Managed operation of AKTA Chromatography, KrosFlo KR2i TFF, and AKTA UF/DF for downstream purification operations • Responsible for hiring, training and managing Outside Service Providers for GMP cleaning of the facility
Education
University of Rhode Island
Bachelor of Science, Wildlife Biology
Skills
- Manufacturing
- Gmp
- Cell Culture
- Lims
- Chromatography
- Purification
- Trackwise
- Glp
- Sop
- Pharmaceutical Industry
- Biopharmaceuticals
- Quality System
- Life Sciences
- Aseptic Processing
- Cleaning Validation
- Protein Purification
- Lifesciences
- Gxp
- Fda
- Project Management
- Filtration
- Change Control
- Six Sigma
- Biotechnology
- Fermentation
- Aseptic Technique
- Capa
- 21 Cfr Part 11
- Technology Transfer
- Validation
- Quality Assurance
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