Tom Cunningham Email & Phone Number

Marlborough, Massachusetts, Us

Coordinate and oversee manufacture of numerous RSM and API sites globally in support of commercial products and development compounds. Drive continuous improvement in process chemistry, unit operations, and project management. Align multiple product launches related to prior approvals (global regulatory) and significant changes (PAS, MAA Variations) in order to incorporate commercial process improvements with regulatory submission cycles.

Irvine, California, Us

Essen, Nrw, De

Lead site Lean Manufacturing & Operational Excellence Implementation. Train and coordinate a team of lean practitioners to facilitate continuous improvement. Develop and deploy continuous improvement master plan. Identify and resource critical continuous improvement projects. Implement lean manufacturing concepts including visual management and daily management along with six sigma methodologies. Employ DMAIC, root cause analysis, and statistical process control and customer feedback to continuous improvement and to development of future greenbelts and blackbelts.Lead critically strategic business line projects at multiple sites in the United States and Canada including the following:• project manager responsible for $9MM greenfield liposomal nanopharmaceutical delivery system R&D laboratory. • Perform collaborative kaizen events with critical customers and lead strategic projects to ensure seamless tech transfer of development and newly approved medications. • Led the construction, commissioning, and qualification of a modular continuous manufacturing unit designed to perform extremely exothermic Grignard reaction chemistry and subsequent continuous extractions.• Project manager for implementation of PAS-X manufacturing execution system (MES) in fermentation, small molecule, and solvent recovery operations. Ensure data integrity and computer systems validation are compliant with cGMP guidance.• Digitalization and Business Intelligence Leader Deploy business & manufacturing IoT devices & applications to automated ETL for digital dashboards. • Evonik lead participant in $4MM NSF grant project collaborating with Harvard and Purdue University research into Artificial Intelligence, Machine Learning, Deep Learning, and edge device deployment leveraging massive amount of enterprise data (ERP, MES, AMS, LIMS, CAPA, Change Control, Automation, Data Historians, and smart sensors/devices).

Essen, Nrw, De

Responsible for the ongoing operation and leadership within an eight unit pharmaceutical manufacturing facility. Managed day to day production of a bulk API small molecule manufacturing plant. Managed dozens of Kaizen rapid planning events and managed the continuous improvement project portfolio. Led several multi-million dollar CAPEX projects successfully to deliver increased flexibility, capacity, new technology and capabilities. Ensure all TrackWise deviations and change controls affecting manufacturing (cGMP, ESH) are thorough, accurate, scientifically correct, and approved within appropriate time lines. Review and approve all validation documentation, master batch records, process hazard analyses, quality risk assessments, and all tech transfer process design proposals new or modified bulk API processes.

Essen, Nrw, De

Supervised four other process engineers and managed supporting tech transfer and process design for new processes coming to the site. Perform small molecule synthesis technical transfer from R&D to pilot plant and from pilot plant to commercial manufacturing plants. Create process scale sheets, master batch records, batch process simulations and campaign simulations (Aspen), cleaning validation protocols, equipment/systems/process validation documentation, process hazard analyses, manufacturability and quality risk assessments, perform structured root cause investigations into major and critical deviations, optimize conditions for reactions, catalysis, crystallization, filtration drying, and other unit operations critical to quality and/or cycle times. Trained new engineers and created numerous technical training packages for engineers and reliability technicians. Expert lead root cause investigator for complex incidents site wide.

Indianapolis, Indiana, Us

Provide analysis and modeling of compensation programs for a global pharmaceutical corporation with 40,000 employees in over 80 countries and provide custom reports for multiple customers; including executive officers, organizational design consultants, and corporate six sigma leadership. Implemented and administered a global employee compensation management program in SAP with a total project cost of $2MM. Received a Global Solution Achievement Award for the team effort to deliver the project. Automated complex, time-consuming data transfer protocols between external business partners to deliver accurate on-line total compensation reports for more than 20,000 US employees.

Indianapolis, Indiana, Us

Leader in HSE providing technical and compliance oversight to pharmaceutical manufacturing, laboratory, maintenance, waste water treatment, and hazardous waste incineration operations. Manage compliance with RCRA generator, RCRA TSDF Part B permit, NPDES permit, Pharmaceutical MACT, Off-Site Waste and Recovery MACT, Hazardous Waste Combustor MACT, SARA, SPCC, HAZWOPER, OSHA, and state regulations. Subject matter expert in IDEM, CERCLA, and SARA immediate release reporting regulations. • Installed and commissioned CEMS and associated data historians for Pharma MACT, Combustor MACT, and OLD MACT reporting in accordance with title V air permits.• TrackWise CAPA event management global design and implementation team member. • Global process engineering best practices review board member.• Lead root cause investigator for high profile events and near misses involving government agency interactions. Hosted several state and federal environmental agency inspections.• Core commissioning team member for a new $70MM RCRA Part B permitted hazardous waste incinerator. Led successful integrated systems testing of a rotary kiln continuous emissions monitoring system (CEMS) to assure DeltaV automation, CEMS, OSI PI data historian, and other system components were capable and compliant with Hazardous Waste Combustor MACT requirements.

Bachelor'S Degree, Chemical Engineering

Master Of Science - Ms, Quality Assurance