IT lead at a clinical-stage oncology company developing monoclonal antibody and CAR-T therapies for the treatment of hematological malignancies and prostate cancer.- Built and delivered new Third-party Risk Management, Vendor Management, Business Continuity, Incident Response, Data Classification and Retention, Generative AI Acceptable Use, and Computer System Validation policies, plans, and procedures.- Developed the company’s first Cyber Resilience strategic plan and program, aligned it with the CIS Top-18 and NIST CSF control frameworks, presented it to the Board for their approval, and trained employees.- Implemented and validated the Box for GxP document management system, qualified Microsoft Azure AD (Entra ID) tenant to support Single Sign On (SSO) for FDA-validated enterprise applications.- Deployed systems for enhancing cyber security protections such as: Mimecast Secure Email Gateway and CyberGraph AI, KnowBe4 Security Awareness Training, Microsoft Defender and Phishing-resistant MFA, 1Password Password Management, Veeam Backup for Microsoft 365.

Led the IT infrastructure team for this biotech specializing in the production of a proprietary enzyme, rHuPH20, used to facilitate the subcutaneous delivery of injected drugs, various auto-injector devices, and hormonal supplements.- Presented with the CEO's Award for leading the IT network and datacenter buildout of the new HQ facility in San Diego. Utilized Cisco Meraki switches and Palo Alto firewalls. The move and cutover occurred as scheduled during the end-of-year holiday shutdown week with minimal disruption to ongoing business operations.- Developed phased integration project plan for merging the IT infrastructure of an acquired company, Antares Pharma, with locations in Minnetonka MN and Ewing NJ, into the Halozyme environment.

IT and Facilities department head at a biotechnology company specializing in the development and commercialization of novel and best-in-class therapeutics to address significant unmet medical needs in neurotology (hearing and balance disorders).- Project manager and tenant representative for construction of a new headquarters building in the La Jolla UTC area. Worked closely with architects and contractors to bring this combination lab and office building in on-schedule and under-budget. Designed and implemented state of the art IT, lab, and utilities systems infrastructure.- Provided key support the successful launch of the company's first commercial product, Otiprio, and the hiring of a national sales force as key member of the project teams for Master Data Management, Customer Relationship Management, Learning Management (LMS), and Mobile Device Management.- Assisted the clinical trials effort associated with earlier stage product candidates through the implementation, integration, and administration of Veeva Vault electronic Trials Master File (eTMF) and Medidata Clinical Trials Management (CTMS) cloud-based software application suites. - Assisted Finance in the transition to and administration of the Great Plains Accounting System and Concur Travel & Expense and Procure-to-Pay modules. Successfully represented IT during SOX audits, with minimal discrepancies noted.- Migrated and consolidated all company servers from a legacy datacenter to a combination of the Microsoft 365 / Azure cloud and the HPE GreenLake edge computing infrastructure platform to reduce costs, improve security and performance.- Implemented Artic Wolf Security Operations Center (SOC) and Security Incident Event Monitor (SIEM) platform, Cisco Umbrella cloud-delivered DNS, secure web gateway, and content filtering.- Led the development of Otonomy's Cyber Resilience Program which was presented to the Board for their review and subsequent approval.

Planned, coordinated, and directed the activities of the IT department at Volcano Corporation, a global leader in diagnostic and therapeutic medical devices for heart and peripheral blood vessel applications. Volcano was comprised of over 2,000 employees located across several international locations dedicated to the mission of developing breakthrough technologies that enable patients to live long and fulfilling lives.- Received enthusiastic Board support for a major, multimillion-dollar initiative to upgrade and consolidate globally-distributed IT systems and enterprise applications on redundant HPE converged infrastructure installed within Switch datacenters located in Las Vegas, NV. All project objectives were met or exceeded.- Created disaster recovery site at the San Diego HQ facility which will allow rapid restoration of service for mission-critical applications in the event of a major casualty, significantly reducing the company's risk profile.- Provided IT support for various M&A activities, including the acquisition of Atheromed in Menlo Park, CA.- Formed the IT Program Management Office (PMO). Conducted assessment studies to justify and deliver major enhancements to the company's Dynamics AX ERP and Oracle Agile Product Lifecycle Management (PLM) applications.- Performed detailed security vulnerability and business impact analysis, remediating findings to significantly improve the company's information security posture.- Led systems integration effort from the Volcano side following the acquisition by Philips Healthcare in February, 2015.

Led the Clinical Operations IT group in providing services to the Process Development, Clinical Manufacturing, Pilot Plant, Drug Delivery, and Site Non-GMP Engineering functions at the Thousand Oaks headquarters campus and other manufacturing/distribution sites world-wide.- Provided key support for the upgrade of the global SAP ERP system to ECC6.- Sponsored successful Werum MES and manufacturing plant data warehouse implementation projects.- Developed new private cloud infrastructure for site-level systems at Thousand Oaks. This was the first use of server virtualization technologies at Amgen for hosting validated manufacturing automation and utility control system applications.- Supported the assessment and reconfiguration of the security architecture for protection of the manufacturing control systems and networks in accordance with NIST and ISA 99 guidelines.- Coordinated a major strategy planning workshop with Operations Technology executive management team.- Assumed responsibilities for providing IT support to the newly-formed Drug Delivery medical device group. Assisted in the evaluation and selection of a Product Lifecycle Management (PLM) application.

Acting IT department head at a life sciences biotechnology Contract Manufacturing Organization (CMO), Althea, and at a Clinical Research Organization (CRO), Profil Institute for Clinical Research (now Prosciento).- Built and validated a new MasterControl Quality Management System (QMS) with modules for CAPA, controlled docs, change control, and deviations tracking.

Directed all IT department strategic, planning, budgeting and operational initiatives for a startup biofuels and specialty enzymes biotech company formed from the merger of Diversa and Celunol in 2007.- Reproduced legacy datacenters using leading-edge technologies following the sale of our biofuels business and facilities to BP: blade servers, high-density storage arrays, VMWare virtual server farms. Reduced physical footprint to 25% of the original. - Re-architected a bioinformatics high-performance compute cluster so that ad hoc BLAST jobs ran on the internal Linux-based blade server farm and batch updates of the primary genomics database ran on Amazon Web Services (AWS) EC2 public cloud servers. Three cabinets containing 105 HP servers were replaced with six blade hosts.- Merged staff, policies, networks and systems into cohesive whole, and relocated the company’s headquarters facility within three months following the merger of the two predecessor companies.- Key member of the project team which successfully built and commissioned the first U.S. demonstration-scale cellulosic ethanol biofuels plant. Installed and integrated Rockwell manufacturing execution systems with PeopleSoft ERP and Maximo asset/maintenance management systems for process costing and inventory control.- Supported launch of Vercipia Biofuels LLC joint venture with BP by facilitating strategic planning and Microsoft Dynamics AX ERP project initiatives with the executive management team. Designed business and manufacturing control systems, networks, and datacenter for a new $350M, 36MGY biofuels plant.- Led corporate-wide initiatives to develop several SharePoint websites for enhancing regulatory compliance, communication with corporate partners, cross-functional project and portfolio management, and the transfer of engineering and scientific data between R&D and Operations.

Led IT team responsible for the design, implementation, and improvement of computer and communications systems which satisfied the unique requirements of the new UCSD Rady School of Management in such areas as instruction, distance learning, fundraising, faculty research, financial reporting, student services, and alumni networks. Reported directly to the Dean.- Designed and oversaw installation of all computer, audiovisual, webconferencing, digital signage, and security systems during construction of Otterson Hall, including “smart” classrooms utilizing leading-edge instructional technologies.- Implemented database applications and advanced reporting services applications for fundraising, customer and donor relationship, student lifecycle information, and distance learning. Integrated them with Office of Administrative and Academic Affairs mainframe systems.- Formed a project team composed of student, faculty, and staff members to define requirements and create a SharePoint-based web-collaboration portal which was successfully rolled out to several hundred MBA students.- Developed a high-level technical architecture road-map and IT strategic plan for the School. This future-state vision was ratified by the Dean and other members of the IT Steering Committee.

Established a top-notch team of finance, IT, quality and project management professionals to support operations across 5 US and European locations with over 5,000 employees following the merger of two major biotech firms, Biogen and IDEC Pharmaceuticals, in 2003. Responsible for managing the global IT department project portfolio and total annual budget of over $100M. Formulated IT regulatory compliance programs and represented the department during FDA, SOX and partner audits. Reported directly to the CIO.- Led the integration team from the IDEC side which developed and successfully executed on a plan to combine several hundred staff, systems, applications, policies, SOPs, and business processes following the merger. - Chartered the IT Program Management Office (PMO), formalized a SDLC project management framework and automated it using forms and workflows developed in Oracle Project Management, Documentum 4i, and Lotus Notes. - Developed quality and regulatory management processes and documentation to comply with rigorous FDA regulatory standards, and consistently passed inspections with few or no exceptions.- Acted as IT project lead for the development and deployment of the company’s new intranet website, iNet.

Hired shortly after the IPO of this pharmaceutical/biotechnology manufacturing firm founded in 1985 and specializing in the production of monoclonal antibodies for the treatment of certain cancers and autoimmune diseases. First IT employee and leader of the IT department until the Biogen acquisition. Grew the department from one to 55 employees, while the company as a whole grew from 40 employees and a $35M market cap to 1,400 employees and a $4.5B market cap. - Evaluated, selected, and implemented all business, research and clinical systems required for approval of Rituxan® and Zevalin®. Rituxan® was the first monoclonal antibody ever approved by the FDA for the treatment of cancer (Non-Hodgkin’s lymphoma) and was one of the best-selling cancer drugs in the world. The Zevalin® BLA was one of the first all-electronic applications ever submitted to the FDA.- Architected and directed construction of a robust IT infrastructure and large datacenters for several major corporate facilities, including the Nobel Headquarters (now Illumina HQ) and the New IDEC Manufacturing Operation (NIMO) campuses (now Roche Genentech). - Formed and chaired an IT Steering Committee to foster collaboration with top executives, drive process improvements, and update the IT Strategic Plan.- Evaluated and deployed enterprise applications including process-manufacturing ERP, warehouse management, clinical trials management, adverse event reporting, IT service and operations management, statistical processing, contract management, sales force automation, laboratory information, enterprise content management, building management, physical security, research informatics, maintenance management, manufacturing execution, database management, and analytics/reporting.- Deployed ITIL-compliant service management platform enterprise-wide for incident, asset, configuration, change, and problem management.

Naval officer (LCDR, O-4, 1120) and Reactor Controls division head on board a Los Angeles class fast attack submarine, USS Bremerton (SSN-698). Qualified in submarines and as a nuclear engineering officer. 5 years active duty followed by 5 years in the Reserves. - Had the honor of interviewing with the founder of the nuclear Navy, Adm. Hyman G. Rickover, for acceptance into the Naval Nuclear Propulsion program. - Joined the boat immediately after Submarine School while she was being built at General Dynamics Electric Boat Division in Groton Connecticut. We must have done a good job of it - by the time she steamed into Bremerton WA after her last sea tour in 2018 she was the oldest boat in the fleet (and proud possessor of Adm. O'Kane's cribbage board), the longest serving boat at the time in US Navy history, and had travelled over one million miles on nuclear power.

Worked under Prof. Medy Sanadidi to run PL/1 network modeling programs on the IBM 360 mainframe computer. Graphed the resulting output data on a Tektronix plotter. UCLA was the site of the first router (IMP-1) on the ARPANET, which was renamed as the Internet after the transition from NCP to TCP/IP protocols in the early 1980s. There were approximately 100 hosts on the ARPANET when I joined the program.