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EMPLOYMENT HISTORY

Roka Bioscience Jan 2010 July 2010


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)

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