Matthew J. Gasparini
Lake Stevens,WA
Summary
An experienced high-tech manufacturing professional with nearly 20 years of experience, 18 of which in the manufacturing of protein-based and CAR-T bio-therapeutics end-to-end processes. Process experience includes media preparation, large & small scale cell culture, as well as formulation and filling of such therapeutics. Known for identifying process gaps and delivering results in process development projects through my certification as a Scrum Product Owner and through other process improvements. As a process SME of the network, I have been relied on to work and travel internationally to participate in tech transfers and ensure understanding of knowledge sharing and training.
Throughout my career I have been selected for leadership roles including Team Lead, Shift Lead, Supervisor, and Senior Manager. I perform at a very high-level regarding delivery on daily operations and side projects in pressure situations, with focus towards right first time and on time while maintaining an enjoyable work environment. I have maintained a disciplined, self-motivating work ethic and an exemplary work record at every position held while being a positive role model.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Senior Manager of Open Operations
BMS/Celgene/Juno Therapeutics
04.2022 - Current
- Hiring, mentoring, and developing exceptional individual contributors and front-line leaders
- Building effective cross-functional relationships both internally within the Bothell Jump Site and externally across the BMS network.
- Ensuring a culture that embraces the safety of the work environment and the safety of the patients through compliance with company procedures and policies, and cGMP requirements
- Participated in the scale-up and operation of the Jump Manufacturing Plant through start-up and PLI
- Establishing department goals, tracking, and reporting KPIs, and driving continuous improvement efforts
- Designing and operating manufacturing systems that are technically sound, promoting effective and efficient operations, and complying with cGMP requirements
- Ensuring the schedules of the people, facility, equipment, materials, and documents are established and maintained to support the capacity/throughput of the facility
- Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients
- Establishing team policies, organizational structure, shift structure, and career ladders
- Ensuring deviations, CAPA, change controls, process transfers, and other business drivers are supported
- Driving right first time (RFT) culture and executes manufacturing unit operations by providing direct training, guidance, and problem solving
- Implementing and managing department/functional group key performance indicators (KPIs) and goals
- Oversee workforce management planning, volume predictions and capacity planning.
- Hiring, mentoring, and developing exceptional individual contributors and front-line leaders
Manager of Media Operations
BMS/Celgene/Juno Therapeutics
05.2018 - 04.2022
- Joined Juno at the JuMP Facility in May of 2018 and quickly learned the media process by becoming a qualified aseptic processor in an ISO5 environment
- Joined the AMPS capital project as the POC for manufacturing to bring a closed large scale automated media preparation solution to facilitate a more ergonomic and efficient means to meet process demands
- Assisted in the design of a new media operations suite which will have more efficient flow paths and ease of production, maximizing the current footprint
- Managed a team of 10 reports
- Ensured associates were fully qualified prior to joining the night shift and promoted ‘right first time’, ATS and quality objectives
- Instrumental in educating night shift associates during the transition to a 24/7 schedule about night shift work and how to cope with any issues that arose.
Senior BioProcess Utility Operator
Genentech, Inc
05.2017 - 05.2018
- Responsible for the operation, maintenance, and monitoring of all critical utilities within a state-of-the-art bio-therapeutics plant while responding to daily field calls to ensure proper function of equipment at the Hillsboro Technical Operations (HTO) facility
- Joined the Hillsboro Utilities Department in May of 2017 and quickly became qualified on the critical utility systems including but not limited to: WFI Generation, RO Generation, Gaseous Systems, Plant Steam, HVAC, Refrigerated Water, Cooling Towers, Process Waste Streams, etc
- Completed operator of record training to be able to monitor all plant systems on an overnight shift
- Versed in Delta V and BAS interface programs that control and monitor system setpoints and being able to respond and adjust systems to maintain plant functions as environments change
- Efficient communication and coordination during environmental events that could potentially impact GMP status and/or Adherence to Schedule (ATS)
- Performance of daily round schedules for inspecting and testing the functionality of critical equipment
- Performance of preventative maintenance, including but not limited to: Pump Swaps, Valve Replacement, LOTO Practices, Filter Swaps, Vibration Analysis, etc
- LPS (Lean Production Systems) rollout department implementation team
- This included training and development of department specific tools.
Shift Lead, Senior BioProcess Technician
Genentech, Inc
03.2011 - 05.2017
- Responsible for the manufacture of protein based liquid and lyophilized bio-therapeutics in a formulation and filling capacity in a state-of-the-art facility while maintaining operations, managing shift assignments, creating accurate reports, and adhering to a fixed schedule
- Joined Aseptic Operations (AO) in March of 2011 and quickly assimilated and learned my job function, where I was quickly promoted to Shift Lead in July of 2011
- Responsible for assigning and managing job duties to actively maintain production schedules, reporting or escalating issues that arose to find a timely resolution to management or a support team
- Versed on the processes associated with the formulation and filling aspects of AO end to end
- Actively current on process revisions and suggesting process improvements to maximize the potential of AO
- Versed in the computer and automated systems which govern the processes in AO such as Delta V and MES
- Syncade SuperUser and member of the Syncade Implementation Team and SuperUser Forum
- Coordinate process and protocol trainings to ensure shift compliance
- Monitor the qualification statuses of the technicians on shift to ensure compliance
- Complete shift reports and schedule updates to disseminate the most accurate and critical information for the oncoming shift
- Able to perform supervisor functions in need arises
- Chairman of the AO STARI Team (Safety) and member of the HTO Training Team (VOC Team)
- Selected and completed the HTO Emergency Response Team Program, Active Member.
Senior BioProcess Technician
Genentech, Inc
09.2005 - 02.2011
- Specializing in the production of mammalian cell-based products by cleaning, sterilizing, and operating fixed vessel systems for media preparation, cell culture fermentation, and harvest operations within the Cell Culture Manufacturing (CCM) Group
- Outstanding interpersonal skills, internally motivated, and excellent leadership experience
- Team Lead of the CCM STAR and 5S teams concurrently and member of the BGA team
- Proficient in SAP, Trackwise, LIMS Labware, POMS and PI
- Creation and ownership of process development and training materials within CCM
- Proficient in handling shift changes, shift wrap up, recipe review and report generation
- Led and resolved numerous safety initiatives including JHAs, led the expansion of the 5S initiative and was instrumental in cross-functional base-lining and audits
- Genentech Certified Trainer and Vacaville Powered Industrial Truck Certified Trainer
- CCM Space Allocation Coordinator.
Education
Executive MBA - Business Administration And Management
Washington State University
Pullman, WA12.2024
Baccalaureate - Social Science, Business Administration
Washington State University
Pullman, WA2022
Master Brewers Program Diploma -
University of California At Davis
Davis, CA2005
Professional Brewers Certificate in Fermentation Science -
University of California at Davis
Davis, CA2005
Skills
- Versed in cGMP/FDA Regulations
- Versed in Syncade MES, Delta V, SAP, Building Automation System (BAS), Honeywell and Siemens Operating Systems
- Certified Scrum Product Owner (2023), Project Planning and Coordination
- Budget Planning/Accounting
- Servant Leadership
- Production Scheduling
- Class A Trained
- Versed in OSHA regulations
Certification
Agile Scrum Product Owner Certification, 2023
Timeline
Senior Manager of Open Operations
BMS/Celgene/Juno Therapeutics
04.2022 - Current
Manager of Media Operations
BMS/Celgene/Juno Therapeutics
05.2018 - 04.2022
Senior BioProcess Utility Operator
Genentech, Inc
05.2017 - 05.2018
Shift Lead, Senior BioProcess Technician
Genentech, Inc
03.2011 - 05.2017
Senior BioProcess Technician
Genentech, Inc
09.2005 - 02.2011
Executive MBA - Business Administration And Management
Washington State University
Baccalaureate - Social Science, Business Administration
Washington State University
Master Brewers Program Diploma -
University of California At Davis
Professional Brewers Certificate in Fermentation Science -
University of California at Davis
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