Mike Bugayong
Marysville,WA
Summary
Results-driven Senior Manufacturing Manager with a proven track record of optimizing production processes and driving operational excellence. Leveraging over 14 years of experience in biotech manufacturing. Successfully overseen large-scale manufacturing operations in purification, cell culture, cell therapy, and fill-finish. Consistently meeting and exceeding production targets while ensuring the highest standards of quality and safety. Known for my adept management style, excel in fostering a collaborative and high-performance culture within cross-functional teams. A proven ability to mentor and develop talent, driving continuous improvement throughout the manufacturing process.
Overview
15
15
years of professional experience
Work History
Senior Manager, Manufacturing
AGC Biologics
Bothell, WA
08.2021 - Current
- Responsible for overseeing 50+ people and supporting all night shift operations, managing escalations, and managing processes in downstream (purification), upstream (cell culture), and support (autoclave and parts washer) areas across four distinct buildings in a large-scale manufacturing facility.
- Interface with third parties for products developed, manufactured, tested, processed, packaged, released, and stored by AGC Biologics.
- Provided strong leadership to enhance team productivity and morale.
- Produced staffing matrix to provide adequate coverage of the department.
- Conducted performance evaluations, compensations, and hiring to maintain appropriate staffing requirements.
- Boosted team member productivity by enhancing performance monitoring and instituting motivational approaches.
- Establishing department goals, tracking and reporting KPIs, and driving continuous improvement efforts.
- Managed large-scale projects and introduced new systems, tools, and processes to achieve challenging objectives.
- Hiring mentoring and developing exceptional people.
- Ordered and onboarded new equipment.
- Building effective cross-functional relationships.
- Ensuring that support is provided for deviations, corrective and preventative actions (CAPA), change controls, process transfers, and other key business drivers.
- Reviewing and approving documents which include standard operating procedures, batch records, and various engineering protocols.
Manufacturing Supervisor
Bristol Myers Squibb
Bothell, WA
06.2018 - 08.2021
- Provide direct oversight of the execution of manufacturing unit operations These operations include but are not limited to the use of the following equipment and or systems (i.e. bioreactors, cell washers, cell separators.), process automation systems (i.e. Unicorn and BAS), and supporting business systems (i.e. Oracle, ETQ, BMRAM)
- Ensure staff are properly trained on controlled, approved GMP procedures Adhere to all plant safety policies and procedures and proactively identify unsafe conditions
- Conduct annual employee performance improvement and development plans
- Manage on the floor production issues cross-functionally
- Complete production plans by scheduling and assigning personnel to daily tasks
- Provide critical communications upwards, downward, and across as deemed fit, manage decisions– acquire feedback, input, and consult as required
- Drives continuous improvements through staff engagement and demonstrates the ability to lead manufacturing operations teams to achieve objectives
- Provide coaching, mentoring, and team building
Senior Manufacturing Specialist
Genentech
Hillsboro, OR
10.2011 - 06.2018
- Adhere to all plant safety policies and procedures and proactively identify unsafe conditions
- Perform safety and housekeeping audits as required
- Participate in RCA's, CR's and Equipment Failure Mode activities
- Perform set up, change over, and test run equipment for various-sized vials as required
- Supporting Production Maintenance, Instrumentation as well as outside services in the repair, maintenance, and calibration of systems as required
- Perform training of other Technicians and Specialists Assist in development and revisions of plant SOP’s and training materials
- Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems)
- Operate all, sterile filling, tunnel, vial washer, Capper, and lyophilizer
- As line 3 sterile operations SME, I am responsible for teaching the line 3 overview course to new employees, as well as existing employees as a refresher course to stay up to date with current training's
- Provide 2nd tier support to technicians
- Conduct environmental monitoring activities in the manufacturing areas as required
- Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output
Commercial Filling Technician
Genentech
San Francisco, CA
08.2010 - 10.2011
- Collaborated with different departments to ensure smooth workflow and efficient organization operations
- Safe and efficient operation of Vial Washer, Capper, Trayer, Autoclave, and Environmental Monitoring equipment: i.e., Climet, Air Ideal & NVP HMI
- Maintain necessary level of communication between shifts
- Follow standards and procedures to maintain a safe work environment
- Notified supervisors of faulty operations and defective materials, via work orders
General Manager
Miki Japanese Restaurant
Modesto, CA
09.2008 - 06.2010
- Managed a team of 25 total employees
- Ranging from dishwashers to department managers Responsible for increasing revenue month after month
- Building team morale
- Responsible for all permits to be obtained
- Employee scheduling
- Taking care of customer complaints when necessary
- Setting and assisting in obtaining business goals
- Work effectively and efficiently in a team-oriented environment in order to create great customer service
- Developed open forum meetings once a week to gather ideas and answer any questions or concerns
- Managed budget implementations, employee reviews, training, schedules and contract negotiations
- Reduced costs, managed delivery schedules and performed risk analysis to improve overall profitability
Education
Associate of Applied Science Degree - Electronics Engineering Technology, Electronics Engineering Technology
ITT Technical Institute
Rancho Cordova, CA06.1998
Skills
- Extensive knowledge of SOPs and cGMPs and the know–how to work and manage within a regulatory environment
- Adaptable to a fast paced, complex and ever-changing business environment
- Demonstrates aptitude for engineering principles and manufacturing systems
- Team Leadership
- Conflict Resolution
- Coaching and mentoring
- Exceptional interpersonal communication
- Performance improvement
- Influencing and Motivating
- Cross-Functional Communication
Accomplishments
- Recognized as being a part of the top 3% in performance.
- Was rewarded with a week all-inclusive trip to Hawaii.
- Directly responsible for 100% yearly sales increase.
Timeline
Senior Manager, Manufacturing
AGC Biologics
08.2021 - Current
Manufacturing Supervisor
Bristol Myers Squibb
06.2018 - 08.2021
Senior Manufacturing Specialist
Genentech
10.2011 - 06.2018
Commercial Filling Technician
Genentech
08.2010 - 10.2011
General Manager
Miki Japanese Restaurant
09.2008 - 06.2010
Associate of Applied Science Degree - Electronics Engineering Technology, Electronics Engineering Technology
ITT Technical Institute
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