David Bourke Email & Phone Number

Multiple

Tunnell Consulting, Program Manager – provided technical and management of multiyear government contracts.TB Alliance/ Gates Foundation, Managing Consultant – provide technology transfer support for TB drugs.Medimmune (AstraZeneca), Sr. Program Manager – provided technology transfer and life cycle management support for Synagis® RSV, FluMist®, IMFINZI™ (durvalumab), FASENRA™ (benralizumab) and tremelimumab. Implemented business/PMO processes and management improvements.Confidential - provided technical CGMP gap and due diligence assessment for Gland Pharma operations at 5 manufacturing sites in Hyderabad India.Spark - provided technical CGMP gap, PAI readiness assessment, and remediation planning for gene therapy operations.Genentech - provided a CGMP gap assessment and recommendations for manufacturing at the Vacaville CA site.National Institutes of Health - provided assessment of the NIH Clinical Center (PDS and Pharmacy) and remediation planning to address the deficiencies identified during the recent FDA inspections. Verdesian Life Sciences – developed long range planning including forecast, capacity, and warehousing. Provided management support for process improvement programs.Institute for Bioscience and Biotechnology Research – provided support for partnering, recommissioning, and validating their CGMP manufacturing facility.Hospira - Provided technical remediation for the Rocky Mount site SOPs. Developed and executed Chemistry, Stability, and Regulatory remediation for the Lake Forest site. Managed external lab method validations and transfers. Managed regulatory filings to closed remediation activities.Boehringer-Ingelheim - Established technology transfer guidance. Managed technology transfer teams to develop, transfer, scale-up, validate and license drug manufacturing. University of Michigan - Developed business and technical proposals..

Established contract, subcontractor, earned value, and risk management governance. Developed and implemented PMO policies, procedures, and tools. Resolved compliance gaps and delivered on contract requirements for three key company products. Deployed Earned Value Management to contract resources and subcontractors. Developed and managed integrated master schedules for existing programs and new proposals.Led the advanced development of an rPA anthrax vaccine under US Government contracts. Established and led a cross-functional anthrax vaccine program team to support government contracts and subcontractor management activities. Established network of subcontractors for executing on contract deliverables. Led the process technology transfer to US CMOs.

Led global multi-disciplined teams developing, manufacturing, and commercializing vaccines. As Smallpox Vaccine Program Leader, completed development, clinical trials, FDA licensure, and delivery of a smallpox ACAM2000® vaccine to the CDC under US government contract in partnership with Baxter Healthcare. Obtained and delivered on a warm-based manufacturing contract with CDC/SNS to maintain the US government smallpox ACAM2000® vaccine stockpiles and FDA license, and to establish domestic manufacturing with annual vaccine doses deliveries. Led the Baxter Healthcare partnership for securing and delivering on international ACAM2000® vaccine contracts for the WHO and 17 countries. Led the acquisition of a BioReliance facility and subsequent planning and scale-up of fill/finish operations. Led technology transfers of bulk drug substance, finished drug product, and diluent products. Led multi-disciplined teams driving Japanese Encephalitis, West Nile, and clostridium difficile vaccine candidates through early phase development, manufacture, and clinical trials. Led process technology transfer to fill/finish operations to Bharat Hyderabad, India. Supported several proof of concept, merger, and acquisition efforts.

Provided vaccine and medical device development, technology transfer, manufacture, failure investigation, and validation services. Executed on corrective actions with specific focus on control systems, HVAC, and vaccine products/ processes.

Managed order processing systems, engineering, tooling, software, maintenance, facilities, and plant operation within the precision component and raw material supply CMO business. Managed technical staff located in two sites.

Led multi-disciplined teams developing, manufacturing, and commercializing ophthalmic class 3 medical device PMMA and foldable acrylic intraocular lenses. Established labs and directed technical staff located in three sites to generate pre-clinical test data under design controls for worldwide regulatory and ISO/ CE Mark technical file submissions. Developed and maintained the five-year pipeline and commercial surgical business strategic, utilization, and production plans. Developed and scaled up in manufacturing new PMMA and MemoryLens® foldable acrylic intraocular lenses. Led the implementation of validated manufacturing improvements.

Managed the development, manufacture, and commercialization of ophthalmic class 3 medical device PMMA and foldable silicone intraocular lenses. Developed and scaled up in manufacturing new PMMA and foldable silicone intraocular lenses (SI30, SI40). Developed and released to manufacturing, an electro-mechanical and optical automation line to manufacture intraocular lenses in Puerto Rico. Designed and released to manufacturing, electro-mechanical process and equipment to perform molecular alignment of plastics to prevent customer complaints of breakage in final products. Implemented validated manufacturing improvements.

Designed and transferred to manufacturing several intraocular lens products, medical device manufacturing systems, and processes. Developed a custom lab to allow surgeons to design and manufacture new discovery optical implants. Designed and transferred to manufacturing, systems and processes to surface passivate intraocular optics as a new low friction product platform.

Mba, Business Administation

Bsee, Engineering