Mike Cullen Email & Phone Number

Camarillo, California, United States

Manage Start-Up activities to establish and scale Cell Therapy Lab Facilities for global and domestic locations.• Facilities Operations o Oversee buildout of office and PD and RD lab infrastructure functions to ensure proper operations and maintenance of all building systems in alignment with quality requirement.o Manage external vendors for janitorial, clean room, facilities maintenance and internal projects.• Lab and Equipment Management o Lead procurement… Show more Manage Start-Up activities to establish and scale Cell Therapy Lab Facilities for global and domestic locations.• Facilities Operations o Oversee buildout of office and PD and RD lab infrastructure functions to ensure proper operations and maintenance of all building systems in alignment with quality requirement.o Manage external vendors for janitorial, clean room, facilities maintenance and internal projects.• Lab and Equipment Management o Lead procurement, coordination and installation of laboratory equipment to enable efficient workflow. Proactively maintained lab inventory required for continuous operations. Primary contact for lab vendors, including supplies, chemicals, gas, equipment maintenance and service.o Effectively used and maintained laboratory instruments such as centrifuges, CO2 incubators, shaker incubators, thermocyclers and related. • Regulatory Compliance o Implemented comprehensive safety (EHS) protocols by developing and monitoring equipment procedures, maintaining certifications for hazardous material handling and waste management, and ensuring compliant transportation of hazardous materials, while overseeing lab infrastructure and vendor management to align with quality and regulatory requirements.o Assist in maintaining necessary certifications related to hazardous material handling, waste management, air quality, environmental, gas and other environmental aspects. o Manage transportation operations, including handling, packaging, shipping and delivery of hazardous materials in compliance with regulations. Show less

People Manager overseeing CMMS, contract workers and vendors delivering operational support for Start-Up Phases in Facilities Maintenance and Project across 6 sites in U.S covering over 200,000 SF and 2,500 assets.• Manufacturing Maintenance o Start-Up of 32,000 SF Clinical Manufacturing site and 36,000 SF PD RD Lab Expansion. Managed IQ/OQ/PQ of 2,000+ GxP assets including equipment receiving, installation, calibration, certification, and validation.o Oversee all Preventative… Show more People Manager overseeing CMMS, contract workers and vendors delivering operational support for Start-Up Phases in Facilities Maintenance and Project across 6 sites in U.S covering over 200,000 SF and 2,500 assets.• Manufacturing Maintenance o Start-Up of 32,000 SF Clinical Manufacturing site and 36,000 SF PD RD Lab Expansion. Managed IQ/OQ/PQ of 2,000+ GxP assets including equipment receiving, installation, calibration, certification, and validation.o Oversee all Preventative Maintenance, Corrective Maintenance, Calibration and Certification work across sites ensuring all work aligned with Quality and EHS compliance.o Technical review of Calibration Certificates from Internal/External service providers.• Asset Management o Implemented and Managed CMMS including inputting all data for each asset. Administrator responsible for Data Integrity, hands-on support for day-to-day work order management.o Support in the development of Asset Management equipment lifecycle with Reliability Engineering team including Bill of Materials and determining critical spare parts.• Facilities and Lab Management o Vendor Management facilities support for Lab, Clinical and Commercial work orders, job plan development, schedule adherence and supplemental documentation. Responsible for Facilities and Maintenance KPIs, work order data extraction and presentation to senior leaders.o Obtain and review quotes, submit requisitions for goods and services related to facility and maintenance activities including external service contracts for critical equipment.o Led training for internal and external users on CMMS and created job aides to help users learn and navigate complicated tasks within system. Show less

Orchestrated critical maintenance operations for 6M+ SF of biopharma manufacturing, driving seamless delivery and compliance through strategic work order management.• Review and approve documentation to ensure that accurate records were submitted and meet all requirements of GMP’s + internal SOP’s; along with current regulatory expectations for GxP pharmaceutical and biopharmaceutical for clinical manufacturing.• Act as System Owner to support compliance asset management creating… Show more Orchestrated critical maintenance operations for 6M+ SF of biopharma manufacturing, driving seamless delivery and compliance through strategic work order management.• Review and approve documentation to ensure that accurate records were submitted and meet all requirements of GMP’s + internal SOP’s; along with current regulatory expectations for GxP pharmaceutical and biopharmaceutical for clinical manufacturing.• Act as System Owner to support compliance asset management creating and updating asset records for new and existing equipment, determining critical spare parts, and driving new equipment projects to completion in the field and within CMMS.• Drive compliance by managing and creating asset classes, labor groups, job plans, and workorder metrics. Act as Point of Contact for audit investigations to pull CMMS data: work order history, asset history and records.• Manage Maintenance, Instrumentation and Certification activity schedule to maintain compliance schedules, KPI’s (cycle time, safety workorders, preventative maintenance workorders, aging workorders), and SLA’s. • Lead other Planning and Scheduling departments across various Internal/External Service Providers as needed to ensure proper resources are available to execute scheduled work.• Create PM/CAL forecasts, communicate to Maintenance, Metrology, Lab Support Management and end users with proper notice to effectively schedule required activities minimizing equipment/system downtime.• Present workorder performance with client management on monthly basis Show less

Newbury Park, Ca