GARY SANTONASTASO

Hillsborough, New Jersey ***** 908-***-****

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A dedicated and highly experienced senior facilities director/engineer with multi-industry experience, specializing in facilities management, space planning, operations management, maintenance and repairs, and program and project management. Applies keen skills across a number of diverse industries, with a keen focus on the biotech/pharmaceutical sectors. Excels at developing new and existing technology while guiding all phases of facility operations, renovations, and construction. Proven success in empowering dynamic enterprises with essential, everyday practices and services.

Continuous Quality

Construction Management

Process Improvement

Purchasing Oversight

Staff development

Budgeting/Expenditure management

EXPERIENCE

PTC THERAPEUTICS, Hopewell, New Jersey Sr. Facilities Director, 2020-2022

Hired and directed staff for facilities supporting manufacturing operation at the new Hopewell, New Jersey research and manufacturing. Commissioned all manufacturing support equipment to meet regulatory requirement for FDA and EMA. Developed long-term capital plan to support site operations.

Supported validation and commissioning of start-up operations in less than one year.

Established facilities operational and capital budgets. Completed 2021 under budget, with annual savings of $500,000.

Received CEO award for 2020 for exemplifying fulfilling mission of the company making every day count

Developed SOW and hired/managed the Integrated Facilities Management team for the PTC site

JLL FACILITIES OPERATIONS/BRISTOL-MYERS-SQUIBB, Hopewell, New Jersey

Senior Facilities Manager/Director, 2015-2020

Oversaw and managed cGMP facilities operations for three sites in New Jersey, supporting office, research laboratories, animal facilities, clinical manufacturing, worldwide data center facility, cafeteria services, and child development center. Led day-to-day operations of all internal staff, including boiler operators, co-gen plant operators, waste water treatment staff, maintenance mechanics, electricians, plumbers, painters, laboratory support personnel, janitorial, mail, pest control, landscape and snow removal, waste/hazardous waste management, and safety and environmental.

Evaluated all outside services contract providers, established contracts, and supervised day-to-day services. Managed operating budgets for all three sites as well as control of spending within contracted budget. Provided budgets and cost estimates for additional capital work outside budget and contracted with BMS. Managed safety program for all internal and external staff. Acted as key BMS contact for all sites, working closely with all levels of management.

Developed and instituted a site wide staffing and operational model meeting Client start up timing.

Met all KPI's and SLA's as required by the contract.

Reduced operating cost by 1.9 million dollars by utilizing internal staff.

JACOBUS PHARMACEUTICAL, Princeton, New Jersey

Facilities Engineering Plant Manager for cGMP Compliance, 2012-2014

Directed and managed all engineering and facilities cGMP compliance projects at API and solid dosage manufacturing site. Oversaw all renovation and expansion construction and maintenance projects. Managed all facility cGMP issues and supported manufacturing on operations related issues and projects. Directed day-to-day operation of engineering and facility maintenance. Managed all cGMP quality maintenance projects. Oversaw construction contractors and project engineers related to renovation of cGMP facility, including API Manufacturing, laboratories for QA and R&D, and finish dosage manufacturing.

Oversaw major capital projects to address site maintenance and cGMP issues. Developed cost estimates for projects. Created SOW, bid projects, selected contractors, and managed projects. Specified, purchased, installed, and commissioned all major API processing equipment and solid dosage manufacturing equipment. Facilitated site safety and environmental. Conducted cGMP inspections of primary facilities to maintain facility compliance. Presented engineering compliance plans to FDA and EMA during audits.

Developed a engineering renovation plan and schedule to upgrade manufacturing facility to meet current FDA and EMA requirements achieved annual FDA inspection with no 483 findings.

Instituted a GMP commissioning plan for the newly renovated space

Upgraded and Validated cGMP HVAC systems to support manufacturing

Operating and Capital budget management.

ADDITIONAL EXPERIENCE

ABM ENGINEERING SERVICES, Wilmington, Delaware, Facility Engineering Account Director, Astra Zeneca Pharmaceutical, 2009-2011. Managed and directed facility services and maintenance for sites consisting of corporate headquarters/research facility of 2 million square feet. Oversaw day-to-day operations of all internal staff, including maintenance mechanics, janitorial, painting, mail, pest control, landscape and snow removal, waste, and A/V department. Evaluated all outside services contract providers, established contracts, and supervised day-to-day services provided by contractors. Managed budgets for all four sites and maintained control for spending within contracted budget. Managed safety program for all internal and external staff.

TEVA PHARMACEUTICAL /BARR LABORATORIES INC., Woodcliff Lakes, New Jersey, Director of Engineering and Maintenance, 2005-2009. Directed engineering, operations, maintenance, and HVAC and boiler plant for manufacturing company consisting of corporate HQ, manufacturing, and R&D locations in New Jersey, New York, Virginia, Pennsylvania, and Ohio. Facilitated capital and operational budget management, facility expansion and operations, master planning, employee relocation, new product and process introductions, environmental and safety, and manufacturing and packaging equipment engineering. Led all facility/equipment engineering and maintenance at multiple sites. Evaluated, selected, and managed all contractors and engineering change control during construction phase.

EI ASSOCIATES, Cedar Knolls, New Jersey, Facilities Engineering and Construction Manager 2005. Guided and directed site engineering, new construction, and renovation for major pharmaceutical manufacturing company consisting of two buildings and 400,000 square feet of space. Worked to evaluate, select, and bid all major construction disciplines. Reviewed and approved all documentation and drawings packages, set schedule, oversaw site construction and contractors, reviewed and approved all invoices, and managed budget. Directed all engineering and construction activity for major design and construction project for launch of $500 million new product. Installed major equipment (IQ) and developed regulatory documentation ..

DPT LABS, Lakewood, New Jersey, Director of Engineering Services, 2004. Directed operations, maintenance, office headquarters, manufacturing, laboratory, and warehouse facilities consisting of five buildings and 600,000-plus square feet. Developed and managed equipment projects, equipment and facilities design projects, automation projects, facility renovations, and capital expenditures. Oversaw company security, mail services, custodial, and HVAC and boiler plant employees. Selected and purchased new aerosol filling and packaging line for $8 million product launch. Led and directed engineering for replacement of manufacturing buildings air system (HVAC), with system design yielding 25% reduction in energy costs.

ÉLAN PHARMACEUTICAL CORPORATION (DELSYS PHARMACEUTICAL), Princeton, New Jersey, Senior Director of Engineering, 1997-2003. Maintained and managed budgets and capital expenditures, clinical manufacturing, facility and equipment design, construction, and purchase, maintenance and utilities operation (HVAC and boiler plant) for design and renovation of office, research, and laboratory facilities. Managed employee relocation, environmental and safety, shipping and receiving, data and voice systems, mail room services, and security (including DEA interaction). Directed facility scale-up from research to commercialization for multiple new products. Authored operating procedures and managed equipment start up and IQ/OQ.

ÉLAN PHARMACEUTICAL CORPORATION (THE LIPOSOME CO.), Princeton, New Jersey, Manager of Engineering, 1996-1997. Managed engineering, operations, facilities, and packaging-related projects for two office/manufacturing sites. Increased manufacturing efficiency and capacity by 20% (and annual savings of $300,000) by installing high-speed biotech packaging line. Engineered new manufacturing quality inspection process, reducing staff and increasing line speed and saving $40,000 annually. Directed selection of engineering firm, selected equipment, and completed engineering documents expanding manufacturing, laboratory, and office facility for $900 million new product launch.

KOLMAR LABORATORIES, Port Jervis, New York, Manager of Engineering Services, 1995-1996. Oversaw and managed engineering and maintenance department for contract manufacturing company. Facilitated HVAC and boiler plant, custodial services, security, equipment and facilities mechanics, construction and renovation projects, and building operations. Reduced operating costs by $500,000 by consolidating manufacturing and packaging facilities. Closed and disposed of second facility. Designed and renovated 50,000 square foot office/research facility and laboratory. Oversaw plant-wide asbestos removal, sanitary waste treatment piping replacement, and underground tank removal projects. Engineered and expanded chemical manufacturing, increasing facility capacity by 50%.

JOHNSON AND JOHNSON (JANSSEN PHARMACEUTICA), Titusville, New Jersey, Director of Engineering Services, 1983-1995. Directed engineering, HVAC and boilers, and facility operations and maintenance for corporate headquarters, manufacturing, research, and product development at multiple sites. Managed daily operations and maintenance of 1.5 million square feet of office and manufacturing facilities (biotech), with yearly capital plan of $250 million and facility operating budget of $20 million. Supervised team of 80 professional, technical, and maintenance personnel. Value-engineered design and construction of 350,000 square feet of office and R&D laboratory facility ($46 million), saving $1 million. Won J&J achievement award for project.

BRISTOL-MYERS-SQUIBB ( ER SQUIBB AND SONS) New Brunswick, New Jersey, Senior Project Engineer, 1974-1983. Managed facility design and construction, and equipment evaluation, selection, specification, and installation of manufacturing equipment. Prepared capital appropriation requests, bills of materials for machine installation and modifications. Implemented new equipment and process improvements for manufacturing new products. Conducted machinability testing. Managed engineering, design, construction, and commissioning of 500,000 square foot laboratory and manufacturing facility. Implemented all-new manufacturing and productions standards. Revised process flows, line layouts, equipment design. Increased department thru-put by 10%, saving $50,000.

EDUCATION

COLLEGE OF NEW JERSEY, Ewing, New Jersey, B.S., Engineering

Mercer County College, Hamilton, NJ, ABS., Engineering

PROFESSIONAL DEVELOPMENT

Johnson and Johnson Quality Training and Continuous Improvement

Six Sigma (Johnson and Johnson Courses)

AFFILIATIONS

International Society of Pharmaceutical Engineers

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