John McNeilly
Problem Solver/ Solution Developer
- Role
- Principal Process Engineer at Kymanox
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
Experience
Principal Process Engineer
Nov 2015 — Present
DHF Remediation Risk assessments: user FMEA’s, design FMEA’s, and process FMEA’s. Process Engineer on SOP generation and design options for allogenic CAR-T cell therapy facility.Process Lead on conceptual design report and preliminary design report client review for allogenic cell therapy facilityProcess Lead on conceptual design report client review for autologous CAR-T cell therapy facilityProcess Lead on Sterility upgrades, conceptual and detailed design report reviews, and Risk Assessments for existing Aseptic Compounding facilities.Process Lead on 5 year Site Master plan for an existing Allergenic factory.Process Lead for Feasibility Study for blood processing facility to upgrade existing facility/ transfer to CMO.Process Lead for Conceptual Design for reconfiguration for an existing Allergenic factory.Facility mold investigation and resolution.Process Lead for Conceptual Design of Facility Design for New Regenerative Medicine Facilities. Technical Lead for Facility Layout reviews, new facility location options, and facility expansions for multiple 503B Compounding Pharmacies. Process Equipment Lead at FDA/ DEA Regulated Pharmaceutical Facility.Technical Lead for Facility Layout and Due Diligence for CAR-T Immunotherapy Facilities.
Education
Queen's University Belfast
BEng, Chemical Engineering
1989 — 1992
Skills
- Contract Manufacturing
- Commissioning
- Biopharmaceuticals
- Purification
- Troubleshooting
- Downstream Processing
- Cell Culture
- Ultrafiltration
- Biotechnology
- Process Engineering
- Fermentation
- Technology Transfer
- Filtration
- Chromatography
- Centrifugation
- Cgmp
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