Matthew Hull

• Cell Culture operations from initial vial thaw to wave seed reactors for scale up to 200 liter production reactor.
• Daily sampling, manual cell counting for viability, drain down harvest and re-feed of reactor operations.
• Termination, tear down, CIP,SIP and subsequent rebuild of production reactors to continue uninterrupted harvest of unpurified bulk.
• Implemented lean manufacturing principles to reduce waste, improve quality, and maximize resource utilization.
• Evaluated equipment performance data against established benchmarks to identify areas for improvement or replacement needs.

• Exceeded daily production targets with consistent attention to detail and commitment to meeting deadlines in clinical manufacturing suite.
• Purification of harvested material into purified bulk solution using chromatography and UFDF filtration systems.
• Assembly, CIP, pressure hold, SIP and disassembly of applicable systems.
• Subject matter expert of sampling instrumentation and viral inactivation.

Effectively and efficiently, performed Cell Culture operations ranging from vial thaw, scale up from seed reactors to production and harvest, trouble shooting, batch record software, peripherals and SOPs

• Subject matter expert for Cell Culture/Upstream analytical equipment including Nova Flex, ViCell, Cedex and integrity testers serving as point of contact for on-site PM's and calibrations
• Effectively track and trend process automation systems (i.e,Delta V and Syncade Interactions, OSI/Pi Historian) for troubleshooting and mitigation of any on floor issues working collaboratively with engineering and automation
• Engages in and supports culture of continuous improvement through ownership of initiatives for work processes, equipment functionality and safe work environment
• Revises and creates process documents (SOPs), supports routine process investigations, batch record review, exception reports and deviation investigations
• Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment
• Collaborated closely with cross-functional teams, ensuring seamless integration of processes across departments.

• Experienced operator in multi-product Cell Culture and Recovery/Capture suite
• Qualified Trainer/Operator of Clarification, UF/DF, Chromatography, Aseptic Processing and multiple testing/measuring instruments within scope of operations
• Author and editor of numerous Batch Records, SOPs and Deviations
• Experienced in execution of Validation and Engineering Protocols
• Involved in Safety Committee, Compliance Team, Spill Response Team, R&D groups.
• Increased overall productivity by training new technicians and providing ongoing support to team members.

• Integral part of validation and shakedown operation of equipment in Central Services department within new Human Genetic Therapies production plant
• Operates Media, Buffer and Glass Wash equipment according to SOPs and cGMP standards
• Maintains accuracy of form prep records, clean room environment, equipment maintenance and trouble shooting to comply with GMP guidelines.
• Performed routine equipment calibration to maintain consistent product quality and adherence to specifications.