Michael Bubnick Email & Phone Number

Lawrence Township, NJ, US

ASO-GLS Sr Manager with primary responsibilities supporting S6A Biologics Clinical Processing Facility and S7 Analytical Strategy & Operations - Analytical Regulated Testing GMP laboratory group. Manage permanent and contracted staff of up to 13 resources responsible for all GMP laboratory instrumentation installation, qualification and PM/PV/Calibration.

Lawrence Township, NJ, US

ECQ-Delivery Manger with primary responsibilities supporting S6A Biologics Clinical Processing Facility and Analytical Strategy & Operations - Analytical Regulated Testing GMP laboratory group in S7, in addition to numerous non-GMP laboratory groups in S7. Manage contracted staff of up to 16 resources responsible for all.

Raritan, NJ, US

• Provide validation support including reviewing and approving protocols, reports and deviations for cold chain shipping validations, centrifuges, cell washers, incubators, refrigerators, freezers, walk-in cold boxes.
• Generate and execute protocols and generate reports for filling lines, refrigerators, freezers, incubators, cold rooms.
• Provide worldwide regulatory agency audit back room support in addition to serving as a scribe.
• Address CAPA observations.
• Create validation process maps for manufacturing processes.
• Revise, consolidate and improve validation guidance within global and site specific procedures.

Downingtown, Pennsylvania, US

• Generated and executed HVAC IOQ and Facility IOQ for 3500 sqft of new class C and D clean rooms
• Critical utilities lead assigned to generate and execute IOQ's and PQ's for critical utilities including new WFI and Clean Steam systems

Downingtown, Pennsylvania, US

• Generated and executed HVAC PQ, Refrigerator and Freezer IOPQ's, Process Validation and Isensix (Building Monitoring System) Qualification documents.
• Developed protocol final reports and deviations.
• Assigned to manage phase 2 build out of current facility which consists of planning and coordination of a new area for relocated equipment, new equipment and systems. Includes maintaining equipment database, performing.

Downingtown, Pennsylvania, US

• K-15 Biologics Expansion Project (new construction portion $170 million project, 140,000 net sqft) Merck, Kenilworth, NJ
• Managed commissioning project team regularly consisting of 4 members, but up to 8 team members at peak. Consisted of document generation and field execution of Installation and Operational Commissioning of over 100.
• Responsible for developing project infrastructure which included generating entire project system list of over 100 systems. Populated components and associated drawings for each system.
• Reviewed over 200 project P&ID's and drawings to determine commissioning system boundaries. Highlighted and defined system boundaries on all drawings for each system.
• Assisted with generation of the project schedule linking predecessors and successors to each system in order to determine commissioning sequence. Assisted with assigning schedule durations for field execution tasks.
• Generated Installation and Operational Commissioning documents for utilities and process systems.

Downingtown, Pennsylvania, US

• Merck, West Point, PA - Bldg 70
• IOQ for various reach-in stability chambers, Bio Safety Cabinets, walk-in cold rooms and a water system. Merck, Rahway, NJ - Bldg 53
• Cold room temperature mapping PQ.Dendreon, Union City, GA - Immunotherapy Mfg Start-Up Fac (160,000 sqft)
• Coordinated and led a 10 member temperature mapping execution team for the validation of 66 Manufacturing Incubators. Dendreon, Morris Plains, NJ - Immunotherapy Mfg Fac
• Temperature mapping activities using Lives wireless data logger equipment for Incubators, Refrigerators, Freezers and Cold Rooms.
• Determined faulty calibrations as the root cause for 30 failing incubators, then scheduled and led an execution team for the validation of 92 Incubators.Schering-Plough, Summit, NJ - Bldg S6 ($220 million, 200,000 sqft)

• Large Scale Erbitux Pilot Plant, Building BB50 ($260 million project, 250,000 sqft)
• Performed P&ID walk downs and protocol execution for utility systems, including air compressors, compressed air coolers, air receivers and dryers.
• Signed utility system As-Built drawings.
• Developed Operational Qualification protocols for multiple bioreactors and media prep tanks.Merck & Co., Rahway, NJ - High Pressure Hydrogenation Pilot Plant Expansion ($30 million project, 36,000 sqft)
• Developed and executed over 50 Installation Qualification and Mechanical Completion (IC) protocols including glass washers, fume hoods, DI water, solvent delivery, HVAC and vacuum systems.
• Performed P&ID walk downs, verifying construction in accordance with design documents.