Responsible for the AjiBio's Drug Product, Drug Substance, Label/Packaging, IT and Facilities/Engineering Operations for its San Diego location. Leads team of 350+ employees for an established CDMO organization with Large Molecule, Aseptic fill finish and finishing expertise

Responsible for Revance's global supply chain network inclusive of all Revance manufactured and distributed products as well as CMO Business Alliance Management. Leads Corporate Facilities function for growing Pharmaceutical company across 4 sites in the United States with 500+ employees

Directs a team of 25 employees/contractors providing engineering, environmental health and safety, space planning, maintenance, calibration, security and real estate portfolio managementLeads a 10-person Supply chain group including Clinical Supply activities for US/Worldwide Clinical trials, Purchasing, and contract manufacturing operations for a Biopharmaceutical operations company consisting of six sites in the United States (220,000 sq. ft.) Cumulatively manages total operating budget of $29 MExecuted project design, implementation and management of $100 MM in capital projectsLed operations team’s successful launch of RHA filler product during COVID pandemic in the United States exceeding revenue targets by 50%Authored and directed COVID response plan for 500+ person companySourced and negotiated successful CMO tech transfer projects and supply agreements in excess of $420 MSr. Director of Engineering, Facilities, and EHS 2008-2017Delivered on time and on budget building construction, commissioning, validation and CDC registration of Tier 1 Select Agent Facility/High Potent Biologics Manufacturing plantManaged all aspects of design and installation of a Commercial Aseptic filling line with Lyophilization with capacity of 8.0 M vials per year on schedule and within budget with zero down time to site manufacturing operationsSkillfully managed IT and validation functions for 4 years within budget and zero unscheduled downtime for IT systemsLed and contributed to obtainment of 10 regulatory permits and licenses for drug manufacturing and related operations at site

Providing consulting for Biotechnology and Pharma companies in facilities, cGMP compliance and real estate management.

NuGEN Technologies, Inc. - Served as owner’s rep and GMP consultant for lease negotiations with savings of $1 M. Construction design, site selection, programming and modification for company headquarters/manufacturing facility. Managed $0.5 M tenant improvement project for new corporate headquarters on schedule and within budget

Provided consulting services for on-time implementation of Enterprise Computerized Maintenance Management Systems & evaluation and modification of GMP/GLP calibration and maintenance programs to ensure on-time needed expansion of manufacturing capacity for orphan drugs

Provided consulting services for equipment liquidation and environmental closure of 200,000 sq. ft facility. Consulted on real estate closure transaction that resulted in $2 M in recognized savings

Led 49-person team responsible for real estate, site selection, engineering, environmental health and safety, space planning, maintenance and calibration of a Biopharmaceutical operation consisting of seven buildings (650,000 sq. ft).Led team responsible for building start up, commissioning, validation, furniture procurement and installation as well as managed move of 650 employees to new campus. Vivarium successfully accredited by AALAC within 9 months of occupancy.Responsible for management of $35MM operating budget for operations including CONUS and EU sites.

Managed 20-person group providing for security, engineering, environmental health and safety, administrative services, space planning, maintenance and calibration of a Biopharmaceutical operation consisting of two buildings (220,000 sq. ft). Responsible for building design and construction, commissioning as well as managed move of 220 employees to new campus. Developed, managed and maintained operations and capital budget of $17MM and $80MM respectively.

Responsible for maintenance and calibration of a Biopharmaceutical operation consisting of three buildings (100,000 sq ft). Functions supported include Fermentation, Purification, Research and Development, Technical Development, GMP Warehouse, Lab Space, and Office Space. Designed and managed small and mid scale process modifications to equipment and clean utilities as well as office and laboratory remodels and resets.Directed the activities of two functional departments, consisting of two contractor calibration technicians and seven engineering technicians to support 24 hours/day 7-days/week operations. Developed, managed and maintained all quality paperwork including deviations, engineering change control, applicable standard operating procedures and non-conforming material reports. Responsible for scheduling and completion of annual preventive maintenance shutdowns.

Directly responsible for managing construction and projects up to $12 M on schedule and within budget. Major projects include 90,000 sq. ft. data center renovation and expansion in historic building, and design and commissioning of 7,000 sq. ft biotechnology suiteDirected the activities of structural, architectural, and MEP engineers and contractors to deliver on time and on budget projects for numerous companiesServed as Liaison between clients and various city planning boards with successful approval for client projects in historical buildings

Managed a 15-person team responsible for maintenance, environmental health and safety compliance and calibration of a Biopharmaceutical operation consisting of six buildings including a Vivarium (140,000 sq. ft) Served as SME for FDA surveillance inspections with no observations/483sSupported design/construction/installation/validation activities for 4 major installations including, the startup of a new manufacturing suite, installation and startup of fermentation trains, installation of Autoclaves and remodeling of various manufacturing areas

Managed Instrumentation and Metrology department for Biotechnology production and research facilityManaged install of fermentation equipment up to and including 2750-liter vessels and associated control equipment on schedule and within budgetValidated and maintained Blue Mountain Calibration Manager Database for GMP calibration and Maintenance activities within 3 months of project start and on budget