Brian Morelli
Peabody,MA
Summary
People first leadership style that can encourage and motivate team members. Meticulous to details and promptness in nature. Able to communicate with all levels of the organization, understanding their needs and providing SME input. I am a highly motivated individual and pride myself on overcoming challenges to meet company goals and deadlines. Knowledgeable in GMP Manufacturing Processes, R&D Lab Operations, Facility Utilities, & Building Mechanicals. Proficient with troubleshooting various automation systems, including DeltaV and MES, and instrumentation/control hardware. Experienced with FDA & Internal Audits, acting as SME for Facilities & Automation in recent audits. Led many projects from initial design to qualification and release. Knowledgeable in standard computerized GMP systems.
Overview
10
10
years of professional experience
Work History
Director of GxP Facilities & Maintenance
Seres Therapeutics
Cambridge, Massachusetts
01.2022 - Current
- Responsible for GxP Maintenance, Automation, and Lab Operations across the Global organization
- Created harmonization of maintenance across multiple sites around the globe
- Responsible for Facility oversight, Lab Operations, and department budgets
- Provide SME audit support for internal, external, and FDA audits
- Identified opportunities for continuous improvements with supporting metrics
- Developed a close partnership with manufacturing to collaborate and solve processing issues
- Responsible for leading the Seres Global GxP Maintenance, Automation, and Lab Operation teams, including recruiting and employee development
- Led the team responsible for establishing global GxP facilities, clean utilities, instrumentation, maintenance programs, standards, and procedures for the portfolio of GxP labs, donor facilities, and GMP manufacturing facilities
- Partnering with the Validation and Quality teams to ensure clean utilities and process equipment are maintained in a validated state
- Created department budgets and adhered to the approved budget
- Make financially responsible decisions to maintain equipment and services appropriately
- Ensure the effectiveness of the preventative maintenance and calibration program of process equipment, instruments, clean utilities, and plant systems
- GMP documentation ownership with responsibilities for periodic review, writing SOPs, Job aids, and Work Plan Templates
- Responsible for asset management and lifecycle management
- Project leader for real estate relocation efforts to consolidate lab, manufacturing, and utility spaces
- The return on investment is Four million annually
- Facilitated professional development programs to build a high-performing team.
- Collaborated with senior leadership to set long-term objectives for the company.
Manager of Automation & Control Systems
Takeda
01.2015 - 01.2022
- Responsible for various Automation Platforms (Process Automation: Allen Bradley / Siemens / DeltaV/ Building Automation: Johnson Controls & Schneider Electric) and Instrumentation & Controls across multiple buildings
- Prioritized Operational Support, Capital Projects, Deviation Investigations, CAPAs, and Continuous Improvement Projects for a team of fifteen direct reports
- Managed multiple shifts, from on-call to 24/7
- Shutdown project prioritizing, collaboration, and execution to improve manufacturing processes
- Maintain Current Good Manufacturing Practices (CGMP)
- Responsible for department budget and accurate PO accruals
- Provide team building and training opportunities to reinforce our commitment to people
- Maintaining 24/7 on call support and 20/7 onsite support
- Collaborated with the Health Safety Environment department by being on the electrical safety team and successfully deploying Arc Flash Gowning material that meets ISO 7 cleanroom standards
- Successfully deployed the new Central Monitoring System (Allen Bradley platform)
Supervisor of Instrumentation & Controls
Takeda
01.2018 - 01.2020
- Responsible for supervising an Instrumentation & Controls Team
- The I&C is part of the first response team for manufacturing, facilities, or building issues
- The seven-person team operates on a shift schedule that is onsite 20 hours a day, seven days a week
- The team needs a wide range of skills (Automation, Electrical, Mechanical, and Safety) to perform proper diagnostics and repairs safely and on time
- Maintaining a high percentage of on-time closures for work orders, PMs, and investigations
- Participate in all facility shutdowns to improve business and reliability of processes
- Development of a cross-functional training curriculum to build team knowledge
- Participated in numerous building shutdowns requiring acute attention to detail to ensure all projects were executed right at the time
- I performed quarterly and yearly reviews of the department budget
- I managed overtime with business-needs justification
- I also reviewed contractor SOWs and invoicing for accuracy
Education
B.S. - Business Administration
Southern New Hampshire University
04-2025
Master Electrical License -
Massachusetts01.2011
Journeyman Electrical License -
Massachusetts01.2008
Northeast Metropolitan Regional Vocational High School -
01.2005
Skills
- Project management
- Equipment maintenance
- GMP documentation
- Problem solving
- Team building
- Reliability
- Effective communication
- Collaboration
Timeline
Director of GxP Facilities & Maintenance
Seres Therapeutics
01.2022 - Current
Supervisor of Instrumentation & Controls
Takeda
01.2018 - 01.2020
Manager of Automation & Control Systems
Takeda
01.2015 - 01.2022
B.S. - Business Administration
Southern New Hampshire University