San Diego, CA 92121 Manager, Facilities Services Roka is a spin-off of GenProbe. It is a 45+ person startup company developing r apid diagnostic testing methods for the food industry. Plan is to be in full ma nufacturing and profitable by Q3-2011. My roles at Roka include: Project Management - Overseeing the $1.5M Tenant improvement phase of the facil ity to prepare the facility for R&D and Manufacturing operations. This included wet lab retrofit, mechanical/HVAC systems and equipment and interior demo/const ruction and interior finishes. Facilities Services - Serving internal customers once the facility was occupied on 3/29/10. o Implemented Facilities work request database to request system and associated business metrics o Routine operation/management of the building management system (BMS) to mainta in environmental requirements and temperature control o Developed spare parts (MRO) inventory o Partner with QA to ensure ISO and GMP standards Instrument/Calibration Manager o Developed the calibration program and associated SOPs o Established instrument database o Maintain all instruments to ensure calibration periodicities were achieved Safety Manager o Develop evacuation plan and train all employees o Established safety policies and procedures o Develop and manage CalOSHA recordable injuries log o Established safety metrics to measure Environmental Health Manager o Develop Implement Injury, Illness and Prevention Plan o Conduct necessary employee training o Interface with external agencies (Fire Marshall, City Inspectors, Air Pollutio n Control District and others on compliance and necessary permitting and occupan cy approval Security Manager o Assessed business objectives and developed and implemented the security system throughout the facility. This included complete rekey of the facility, camera system selection/installation and card access management Shipping and Receiving Manager o Coordinate with shippers and take receipt of deliveries to ensure that all cus tomers received the necessary materials to support operations
Denzephia Inc. May 2008 - Current
Bonsall, CA President/CEO Pharmaceutical Compliance Consultant I am the sole owner and active consultant responsible for providing compliance s olutions in the Pharmaceutical, Medical Device and Biotech industries with a foc us on Facilities Services, Maintenance and Instrumentation programs, procedures and policies. I consult for various cGMP Pharmaceutical and Biotech companies i n San Diego County to bring the Maintenance and Calibration programs into compli ance and/or to generally improved upon or and to become more efficient. This is done by conducting a initial gap analysis and providing areas where compliance is in question or that there are opportunities for improvement or cost savings. Additionally, I provide services to draft, implement and train staff on these n ew/improved programs, procedures and policies. Genentech Inc. Nov 2007 May 2008 Oceanside, CA Associate Director, Facilities Services and Projects Genentech purchased the manufacturing site from Biogen/IDEC in Oceanside, CA tha t had been built by IDEC/BiogenIDEC and converted employees necessary to manufac turing as Genentech employees. My role did not change only the company name the building did. o Responsible for leading and managing specialized projects Genentech Oceanside, biologic manufacturing facility. Provided hands on, technical and managerial pr oject oversight and coordination of various specialty projects within the Facili ties Services organization. Projects included: * Oliver Wight, Class A * DMAIC process implementation * Business Continuity Planning * PM-SAP implementation/integration globally across all site * Operational Excellence initiatives * Sustainability associated with Green project implementation and carbon footpri nt reduction * Global business process improvement projects related to gaining efficiencies a cross the Facilities Services organization IDEC/BiogenIdec/Genentech Inc. Feb 2001-Nov 2007 Oceanside, CA Associate Director, Facilities Services & Operations I was responsible for overall strategic leadership and management of the Facilit ies Services organization at Genentech Oceanside, biologic manufacturing facilit y. Department responsibility for 50+ FTEs as well as 50+ full-time contracted/o utsourced staff and ancillary functions. Annual expense budget responsibility e xceeded $ 20M and capital projects budget of approx $10-15M. Functional respons ibilities and sub departments overseen included: o Plant/Utilities Operations: Plant/Utilities operations, production maintenanc e and HVAC o Real Estate Management: Strategic space planning, site master planning and a ll facilities services contracts o Metrology/Instrumentation: Metrology and Instrument Services. Routine calibra tions 10,000+ instruments o Maintenance Systems: MRO Inventory/Parts management, CMS/CMMS information sys tems and all cGMP compliance documentation and QC Labs support and glass wash fu nctions Provide leadership coaching and career/personal development plans for teams and individuals Ensure overall continuous cGMP and GLP inspection readiness and FDA compliance for Facilities Services processes, people, systems and documentation Accountable for maintenance and repairs of all building/facilities systems, cen tral plant, process manufacturing equipment, clean utilities and instrumentation across multiple facilities at multiple sites Develop strategic staffing plans, department goals and objectives, expense and capital budgets to meet corporate objectives and site demands Deliver integrated business continuity and sustainability planning in partnersh ip with other sites and teams Lead teams to continuously improve systems, processes and staff/organization to enable greater efficiency, reduce cost while working to achieve continuously h igher levels of customer service and satisfaction Responsibility during construction of current facility and ultimate start-up op erations, for all Facilities staff throughout construction, start-up/validation and ultimately routine operation of new (current) multi-building, manufacturing campus exceeding 500,000 sqft. Oversee strategic sourcing of all external support service providers, vendors a nd contractors to ensure high level of vendor performance and competitive pricin g Provide department leadership and representation in support of due diligence ef forts, business acquisitions and merger related integrations Develop strategic partnerships and relationships across all sites including cor porate headquarters and other manufacturing sites globally to facilitate standar dization of processes, identify leveraging opportunities and process alignment a cross sites Quidel Corporation Aug 98 Jan 01 San Diego, CA Manager, Facilities/Maintenance/Calibration Overall responsibility for all production equipment maintenance and calibration s including: Lyophilization, dehumidification, dry rooms, clean rooms, auto-asse mbly, packaging, labeling, and pouching equipment Responsible for all facilities systems including HVAC, electrical distribution systems, major building systems and plant operations. Manage planning, budgetin g, capital project evaluation/analysis and tracking for $2M operating/expense bu dget and $6M capital budgets Oversaw Manufacturing Engineering technician group in support of all production and manufacturing equipment as well as Facilities Maintenance group in support of all facilities and plant engineering issues Ensured that programs and documentation compliance in accordance with cGMP, EPA , and ISO 9000 regulations in 72,000 sqft invitro-diognostic device manufacturin g facility and 25,000 sqft medical device manufacturing facilities as well as 20 ,000 sqft office space facility in multiple locations Responsible for site security at all facilities/sites controlling and integrati ng card access, and CCTV systems as well as physical key distribution system Managed activities related real estate, new facilities appropriation and acquis ition, design/construction and relocation as well as all tenant improvements and project management
Medtronic Interventional Vascular May 96- Aug 98
San Diego, CA Facilities/Maintenance Supervisor Responsible for all aspects of facilities, plant/utilities and production equip ment management within the Facilities organization Managed all facilities employees and external contracted services in 120,000 sq ft facility Managed department budgets, goals and objectives, staffing plans and reporting functions Managed multiple physical improvement projects Managed security function and security system Partnered with IT/IS on operations and maintenance of main phone switch and all adds, moves and changes UCSD Medical Center, Thornton Hospital Feb 93 May 96 San Diego, CA Facilities Engineer - Systems Specialist Functioned as Facilities Team Leader in a cross-functional, self-directed work team environment Supported mechanical procurement installation coordination Department budgeting and PO management Maintain the water treatment program for all mechanical systems in addition to Facilities and Plant Operations routine responsibilities Responsibilities included support of hospital equipment and work order manageme nt process/program. Additional responsibilities included operation and maintena nce of all facilities and plant/utilities equipment/systems, preventative/predic tive maintenance and repairs as well as energy management via automated building management system (Johnson Controls Metasys system) and staffing coordination t o maintain shift schedules United States Navy Sept 86 Sept 92 Served aboard - USS New Jersey (BB-62) in Long Beach, CA and USS McKee (AS-41) i n San Diego, CA Enlisted as a Boiler Technician Attended Naval courses and training related to the function Served in Operation Desert Storm 1991 Attended various specialized technical schools during tenure Honorably discharged with numerous meritorious awards and Good Conduct.
Education and Certifications
Bachelors of Science degree - Business Management - University of Phoenix - San Diego, California Multiple leadership, management and cGMP training courses and certificates Multiple training and certificates in personal development, change management a nd employee development Multiple training certificates on computer programs - MS Visio, AutoCAD LT, Pro ject, Power Point, Excel, Word etc. Familiar with most ERP systems (SAP, BAAN, etc) as well as specialized CMMS sys tems specific to Facilities/Maintenance/Calibration Management (DataStream - MP2 /7i, CalMan, ProCAL, PM-SAP, etc)
Professional Affiliations International Society of Pharmaceutical Engineers (ISPE)