Gary Santonastaso
325 Amwell Road
Hillsborough New Jersey 08844
(908) 359-6342 (908) 963-0366
Experienced Engineer, Professional, and Partner with an extensive background in all phases of pharmaceutical and biopharmaceutical manufacturing, packaging, operations, and maintenance. A proven leader with a solid track record in developing new and existing technology, results oriented and problem solver in a highly regulated and fast paced environment. Principle strengths include:
Facilities, Utilities, and Manufacturing Operations Management
Facilities Engineering, Design and Construction, and Project Management
Packaging and Manufacturing Equipment Engineering and Maintenance
Equipment and Facility Commissioning and Qualification
Automation and Cost Reduction Program Development and Management
Contract Development and Negotiations
New Technology Development, Product and Process Scale-up
Security, Safety (OSHA), and Environmental Engineering
Management and Organizational Development of Professional, Technical, and Union Personnel
Purchasing Administration, Operating and Capital Budget Development and Management
Food and Drug Administration (FDA) Regulations and Current Good Manufacturing Practices (cGMPs)
Commissioning, Installation Qualifications (IQ), and Operation Qualifications (OQ) of Facilities and Packaging Equipment
Lean Manufacturing, SAP, Continuous Quality and Process Improvement Program Management
Potent Compound Manufacturing and Engineering experience.
PROFESSIONAL EXPERIENCE
Barr Laboratories Inc., Woodcliff Lakes, New Jersey 2005 - Present
Director of Engineering and Maintenance
Directs the engineering, operations, maintenance, for a Major Pharmaceutical manufacturing company consisting of manufacturing and R&D locations in New Jersey, New York, Virginia, Pennsylvania, and Ohio Responsible for capital and operational budget management, facility expansion and operations, master planning, new product and process introductions, environmental and safety, manufacturing and packaging equipment engineering.
Directs all facility/equipment engineering for new product introductions at multiple sites.
Evaluates all engineering documentation and drawing package, revise documents to meet current cGMPs and state/local construction regulations.
Evaluates, selects and manages all contractors and engineering change control during the construction phase.
Hires and directs engineering, equipment mechanics, and facilities staff of 100 professional and technical employees (8 Direct Reports). Writes department-operating procedures.
Capital plan management of $100 million (Multiple projects $15 to $5 million) and operating budget management of $30 million yearly. Manages construction projects to $50 million
Directs day to day facility maintenance operations at all sites.
Provides engineering and manufacturing designs and support for the handling of high potency and regulated products.
Directs the design of new and specialty equipment used in the manufacturing of new drug delivery technology
Supported the installation of SAP into the maintenance organization for Work orders, PMs, and calibration
Successfully launched SAP into the Engineering and Maintenance organization at multiple manufacturing and R&D sites.
Directs environmental programs for air emission and process waste. Deals with Local, State, and federal agencies at all sites.
EI Associates, Cedar Knolls, New Jersey
Engineering (Contract) 2005 2005
Directs the site engineering, new construction, and renovation for a major pharmaceutical manufacturing company consisting of 2 building and over 400,000 sq. ft. ($25 million) Evaluates, selects, bids all major construction disciplines. Reviews and approves all documentation and drawings packages, sets schedule, directs site construction and contractors, reviews and approves all invoices, manages budget.
Directs all engineering and construction activity for a major design and construction project for the launch of a $300 500 million new product.
Evaluates all engineering documentation and drawing package, revise documents to meet current cGMPs and state/local construction regulations.
Installs major process equipment (IQ), and develops documentation for validation.
Start up all major utilities and develops validation documentation and directs IQ/OQ.
Evaluates, selects and manages all contractors and engineering change control during the construction phase.
DPT Labs, Lakewood, New Jersey
Director of Engineering Services (Contract) 2004 - 2004
Directed the operations, maintenance, manufacturing, laboratory, and warehouse facilities for a pharmaceutical manufacturing company consisting of 5 buildings and over 600,000 sq. ft. Developed and managed packaging equipment projects, equipment and facilities design, automation projects, facility renovations, and capital expenditures. Managed company security, mail services, and custodial staff employees.
Selected and purchased a new aerosol filling and packaging line for an $8 million product launch.
Directed engineering for the replacement of the manufacturing buildings air system (HVAC). System design to yield a 25% reduction in energy costs.
Managed roof replacement project for 5 buildings, replacement of the manufacturing compressed air system, and replacement and upgrade of 200,000 sq. ft. of manufacturing floors.
Managed staff and operating budget for 40 professional, technical, and union employees
lan Pharmaceutical Corporation (Delsys Pharmaceutical), Princeton, New Jersey (Facility Closed)
Sr. Director of Engineering 1997 - 2003
Managed budgets and capital expenditures, clinical manufacturing, facility and equipment design, construction, and purchase, maintenance and utilities operation, office, research and laboratory facilities design and renovation. Managed construction, employee relocations, environmental and safety, shipping and receiving, Data and voice systems, mailroom services, security (including DEA interaction).
Hired by CEO. Established engineering department for a new venture capital company created to develop and commercialize new pharmaceutical and biotech manufacturing technologies.
Directed product and facility scale-up from R&D to commercialization for three new products.
Designed and developed a dry powder inhaler system. Sales projection of $100 million.
Negotiated and administered contracts for a $60 million dollar project for design and construction of manufacturing equipment and facilities.
Managed the validation of both equipment and facilities. Authored operating procedures, IQ/OQ, and equipment validation protocols.
Built and managed 50,000 sq. ft. of office, biopharmaceutical laboratory, research and clinical manufacturing facilities (clean rooms), relocated 60 employees, wrote operating procedures, inspected and successfully received FDA site approval ($25 million project). Establish preventative maintenance program and system.
Directed operations of clinical manufacturing facility and personnel.
Obtained 3 patents for equipment designs and technology advancement.
Negotiated facility lease with a savings of $35K annually.
Hired and directed engineering, equipment mechanics, and facilities staff of 50 professional and technical employees. Wrote department-operating procedures.
Engineered security system, wrote operating procedures, received Drug Enforcement Administration (DEA) approval
Managed the closure of multiple facilities
lan Pharmaceutical Corporation (The Liposome Co.), Princeton, New Jersey (Facility Closed)
Manager of Engineering 1996 - 1997
Managed engineering, operations, facilities and packaging related projects for 2 office/manufacturing sites.
Successfully increased biopharmaceutical manufacturing capacity by 20% with annual savings of $300K by installation of high-speed liquids packaging line.
Directed the selection of engineering firm, selected equipment, and completed engineering documents expanding the biotech manufacturing, laboratory, and office facility for a $900 Million new product launch.
Managed validation and commissioning of the biotech process equipment to manufacture $80 million biotech product.
Engineered new biotech product inspection process reducing staff and increasing line speed saving $40K annually.
Kolmar Laboratories, Port Jervis, New York
Manager of Engineering Services (Contract) 1995 - 1996
Directed the engineering and operations department of a contract manufacturing company. Managed facility design and construction, custodial services, security, equipment mechanics, and building operations with staff of 60 employees.
Successfully reduced operating costs by $500k by consolidation of manufacturing and packaging. Closed and disposed of second manufacturing facility.
Designed and renovated a 50,000 sq. ft. office/research facility, and QA/QC laboratory. Fast track project completed in 3 months ($35 million project).
Plant wide asbestos removal, sanitary waste treatment piping replacement, and underground tank removal projects. Regulatory requirement to meet federal environmental regulations.
Managed productivity and equipment replacement projects with annual savings of $50K.
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 and operations for manufacturing, research, and development. This included new facility and process design/development, selection of engineering firms, and construction management. Managed environmental engineering, package equipment engineering, maintenance mechanics, facility maintenance and custodial staff, grounds maintenance staff, security, administrative and contract services, cafeteria, mail room, reception center, MRO purchasing, contract negotiations and management, receiving, and warehouse operations.
Managed the operations of 1.5 million sq. ft. of office, biotech and solid dosage research and manufacturing facilities with a yearly capital plan of $250 million and facility operating budget of $ 20 million. Managed a team of 80 professional, technical, and maintenance personnel.
Negotiated building and cafeteria services contract with annual savings of $50K.
Successfully value engineered design and construction of 350,000 sq. ft. office and R&D laboratory facility ($46 million) saving $1 Million. Won J&J achievement award for this project.
Managed relocation of offices and labs to a new building for 500 employees in 4 days.
Designed, renovated, and commissioned a 20,000 sq. ft. ($25 million) office and manufacturing facility in Puerto Rico. Project also included purchasing, installation, IQ/OQ, of two tablet packaging lines. Inspected and received FDA approval. Project completed $500K under budget.
Directed renovation, expansion and validation, of 70,000 sq. ft. ($35 million) biotech manufacturing facility (clean rooms). Wrote operating procedures, IQ/OQ, and commissioned facility. Inspected and received FDA approval. Increased productivity 40% by installing new inspection and packaging technology and achieved annual savings of $3 million.
Managed design and construction of 20,000 sq. ft. ($25 million) manufacturing, laboratory, and research/development facility in Puerto Rico. Project expanded product life cycle of a $500 million product brand using a new technology of manufacturing (Instant Dissolve tablet).
Successfully managed closure and consolidation of 70,000 sq. ft. biotech facility with relocation of the operations to Puerto Rico. Annual savings of $15 million. Won Presidents award for this project.
Engineered and installed two power plants. (One in New Jersey and second in Puerto Rico) Replacement of warn-out equipment.
Purchased, installed, and validated (IQ/OQ) 7 manufacturing and packaging lines for the manufacturing of tablets, liquid, and biotech products. Expanded production capabilities to meet $900 Million sales forecast.
Reduced operations and maintenance costs for office headquarters saving $150K annually.
Designed and installed building security system, wrote operating procedures, managed security force. Inspected by DEA and received approval.
Successfully established preventative maintenance program and system for all packaging and facility equipment (Biotech and Solid Dosage).
Managed contract manufacturing services at three contract manufacturing companies with product sales of over $80 million.
Directed the MRO Purchasing Department for entire plant site.
Bristol-Myers-Squibb (Formally ER Squibb and Sons), New Brunswick, New Jersey
Senior Project Engineer 1974 - 1983
Managed facility design and construction, equipment evaluation, selection, specification and installation of filling, packaging and processing 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 for revised packaging methods and materials.
Managed the, engineering, design, construction, and commissioning of 500,000 sq. ft., laboratory, and biotech manufacturing facility. Received FDA approval. Budget management of $80 million dollar project.
Implemented facility and process cost reduction projects on an annual basis with a reduction of operating cost of $50K.
Managed equipment, packaging automation and replacement projects, and new technology development with a cost reduction of $400K.
Implement new manufacturing and packaging productions standards. Revised process flows, line layouts, equipment design. Increased department thru-put by 10% saving $50K.
Education
College of New Jersey
Ewing, New Jersey
Bachelor of Science Engineering (BS)
Mercer County College
Hamilton, New Jersey
Associates Bachelor of Science (ABS)
Architectural Engineering/Design and Construction
Johnson and Johnson Quality Training and Continuous Improvement
Various Training Programs (Six Sigma)
Other Activities
Member of the Hillsborough Twp Planning Board 8 years
Certified Police Officer Hillsborough Twp. 18 years
Member of the International Society of Pharmaceutical Engineers
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