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.

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..
• 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.
• Digitalization and Business Intelligence Leader Deploy business & manufacturing IoT devices & applications to automated ETL for digital dashboards.

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.

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.

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.

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.
• 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.

Bachelor'S Degree, Chemical Engineering

Master Of Science - Ms, Quality Assurance