Full accountability for manufacturing, engineering, validation, and quality control functions associated with the delivery of biopharmaceutical bulk drug substance and drug product. Multi-product facility capable of the simultaneous manufacturing of biopharmaceuticals expressed in mammalian or microbial platform technologies, with recent expansion and start up of Viral Vector facility supporting the Cell & Gene Therapy platform. Also responsible for contract management and oversight of 3rd party CMO activities. Manufacturing functions include cell banking, and cell bank manufacturing, plant operations, raw material procurement, and technology/process transfer supporting both bulk API and Drug Product. Quality control functions include raw material, in process, product release and stability testing, analytical tech transfer to world markets, compliance systems including IT systems, and document control functions. Engineering & validation functions include project and process engineering, instrumentation, control systems, and preventive maintenance systems. Validation activities include validation maintenance and life cycle management for plant equipment and laboratory instrumentation. CMC coordination activities include resolution of cross portfolio items affecting the progression of assets including the resolution of regulatory concerns resulting from submission documentation. Responsible for ensuring cGMP compliance of facilities and systems associated with areas of responsibility. Author of GSK's product quality risk treatment plan.

International responsibilities for management of GMP Operations including Clinical Manufacturing, Quality Control, Engineering & Maintenance for multi-product biopharmaceutical facilities located in the US & UK. Responsible for GMP Operations group consisting of approx. 180 people with operating, expense, and capital budget of $35M.

Responsible for all plant production, engineering, maintenance, capital projects, and associated financials in support of a 80,000 ft2 biopharmaceutical GMP clinical trial production facility. Facility contains both microbial & mammalian production suites to manufacture bulk drug substance.

International responsibility for Facilities, Process & Project Engineering, Technical Services, and validation functions in support of manufacturing and QC staff, and for the development and deployment of IT systems. Direct project management, control systems engineering, & IT systems located in the US & UK. Direct validation functions for process equipment, utilities, and computer systems. Negotiate third party contracts and service agreements. Lead Facilities Master Planning activities for the Division including site development plans, business case development, capital funding allocation and prioritization. Directly Responsible for $ 40 Million biopharmaceutical facilities renovation project to produce cell culture, microbial expressed proteins and downstream purification. Facility also includes QC, cell banking, and process development facilities to support production of bulk drug substance. Chaired the UM Site Safety Committee.

Responsible for all plant engineering activities for Lyondell/Equistar’s largest manufacturing complex located in Channelview, Texas with plant asset value in excess of $ 7 Billion. Major responsibilities included:• Develop & Manage plant reliability and maintenance engineering organization consisting of Static, Rotating, Instrument, Electrical, Inspection, Document Control, Capital Projects, and QA/QC Groups. Manage department headcount in excess of 100 persons plus contract staff. Operating budget of $25 Million, and plant capital projects budget on the order of $35 M. • Lead best practice teams to optimize operating, maintenance & spare parts, and operational excellence standards.• Represent manufacturing facilities discussions with local civilian community and environmental groups including the TNRCC & local EPA on plant related activities affecting the surrounding areas. Public relations trained as part of disaster management.

•Based in the Netherlands, responsible for supervision of local staff and contract employees, and for all engineering support as required to complete the development of equipment design, procurement, and construction specifications for pressure vessels, piping, materials, rotating equipment, fired equipment, and civil engineering disciplines, for the $ 750 Million green field project. •Interface with contracts, process, instrument, electrical, project, operations, and construction engineering groups to assure consistency in the lump sum project design package. •Direct contractor lead discipline engineers in static, fired, piping, and rotating equipment and civil engineering disciplines to assure compliance with conceptual design basis and corporate engineering specifications.•Develop value-engineering opportunities to reduce capital investment while improving equipment reliability.•Provide recommendations to quality management regarding vendor qualifications, technical audit protocols, and shop and field surveillance, to assure compliance with specification requirements during shop and field construction activities. Included considerations for east Europe, west Europe, and Asian based vendors.

Execute projects with Capital spends in the $3 –5 Million range.