STEPHANIE BAMBROOK

Integration Project Manager responsible for implementing systems globally for Takeda. Projects consist of the following:

• Project managed the development and implementation of Kaleidoscope which utilizes Sinequa’s platform, to provide single point search capability to over 60 million documents from external and internal sources for various defined facets
• Migrated on-prem sources from Sinequa’s Profiles platform to Sinequa’s SBA SaaS platform
• Worked with internal team and vendors to develop a KnowledgeNow portal to centralize the user experience for R&D users that bring together news, studies, publications, pre-clinical, pipeline and products and diseases, utilizing various sources: subscriptions, cross portfolio databases and internal repositories
• Piloted Sinequa’s Neural Search product
• Artificial Intelligence: Piloted Bedrock with Cohere and Jirassic Mid as well as Azure with ChatGPT 4
• Implemented Certara D360 at multiple locations globally
• Managed the development of a data warehouse
• Developed road maps with Product Owners
• Managed projects utilizing Agile/Scrum with teams that are located globally
• Managed budget and processed PO’s utilizing Ariba
• Projects are developed utilizing Jira and Confluence and Teams
• Trained and mentored project team on agile (SCRUM)

Responsible for managing project portfolio for Bristol Myers Squibb's R&ED department, that consists of over thirty projects. Projects are new application development within Celgene’s Amazon Web Services (AWS) cloud, vendor implementations, major and minor application upgrades.

• Developed and managed SOW’s budgets, project schedules, risks, issues, user acceptance testing, and change requests for the following projects:

Capital Projects - New application development:

• Managed the development and deployment of a Lab Instrument Mobile Alert Project in AWS cloud that monitors lab instruments and sends alerts to a user’s mobile device (IOS and Android) in the event that an instrument is having any issues during laboratory testing. Project also included a full administration module. This project won the 2018 Bio-IT Best Practice Award
• Data Visualization project for Translational and Clinical utilizing Spotifire and Perkin Elmer’s CDR module. Managed the development and implementation of seventeen visualizations

Vendor implementations:

• Bioption, Virscidian, Biacore, ACD Lab MetaSense, UCSC Genome Browser, Xybion, KNIME, Spotfire CDR

Upgrades:

• Upgraded and migrated Spotfire v7.11 and GeneData 7.1 from on premise to AWS cloud
• Upgraded Pipeline Pilot to 9.2

Manage business analysts, developers, testers, enterprise architects, and infrastructure teams locally and remote.

Developed workflows for training purposes and developed bi-weekly, monthly and quarterly status reports.

Develop and present slides for stage gates.

Projects are developed utilizing Waterfall and Agile/Scrum Methodologies using Microsoft Project Server, Jira and Confluence.

Project Manager, responsible for leading the efforts through vendor selection and implementation of Starlims v11 Laboratory Information Management System.

• Developed user needs/requirements for U.S and International sites
• Developed RFP and vendor score card
• Worked with Starlims on gap analysis and SOW
• Developed and managed budget and project schedule
• Developed risk plan and risk assessment
• Documented as-is and to-be workflows for clinical trials and diagnostic testing
• Managed integrations to instruments as well as Microsoft Dynamics NAV ERP System
• Managed the development and execution of IQ, OQ, PQ as well as master validation plan and traceability matrix

Project Manager responsible for the development and implementation of LIMS Unilab 7.0 for Arthrex R&D laboratory. Arthrex has partnered with Siemens to develop this platform. My responsibilities include the following:

• Managed project from initiation through project closure
• Managed on-shore and off-shore teams for the development of LIMS which includes: sample management, test methods, worksheets, configuration management, user administration, instrument interfaces and SSRS reporting
• Managef the development and approvals for requirements, risk assessments, test plan, traceability matrix, release management plan, support plan, validation plan, IQ-OQ-PQ protocol and test case execution, validation summary report and the development of SOP’s
• Created and maintained project schedule, issue log, budget, risk management, burndown charts, and KPI’s and status reports
• Managed infrastructure team to set up five hardware environments
• Develop and present slides to the Executive Steering Meeting Committee for Status Reporting and Stage Gate Exits
• Net environment, SQL Server, HP/ALM, Workfront

Project Manager responsible for the management of retrospective equipment qualification on over 100 laboratory devices

• Worked with the management team through the vendor selection process
• Created and maintained RFP, project schedule, budget and status reports
• Managed Perkin Elmer and internal personnel for the scheduling of equipment down-time for qualification within 12 laboratories
• Managed IQ, OQ and PQ development and execution
• Created Qualification Summary Report for all devices
• Developed business case for LIMS software and note books

Program/Project Manager responsible for the development and implementation of the following systems:

• LabWare LIMS to support Dermagraft product
• Enhancements to QAD ERP system
• Enhancements to Radley Barcode Labels
• Manage teams that consist of Business Analyst's, Developers, Architects, Testers and Vendors
• Develop and maintain project schedule, budget, risks, and issues logs
• Work with the business to develop SOP’s and training materials
• Project Manager for the divestiture of Shire Regenerative Medicine
• Project managed the transition and integration of IT Infrastructure, Applications, Web Domains and Web Sites to Organogenesis
• GMP, 21 CFR Part 11 Compliance, IQ,OQ,PQ Protocols

Program Manager for in-house developed Enterprise LIMS system, with multiple integrations through an ESB. Integrations include: Illumina’s portals, instruments, equipment management system, JDE, reporting, and learning management system. Agile/Scrum Methodology.

• Led development team through a vendor selection process for a Laboratory LIMS solution
• Developed score card and worked with various vendors
• Worked with internal business and developed requirements for SaaS portal solution for Illumina’s CLIA Laboratory, and led team through the vendor selection process
• Developed budgets, project schedules, status reports and communication plan
• Manage risk, issues, and validation plan
• Create and present presentations for stage gate exits
• Net, Java, and SQL environment HL7 and Web Services integrations
• 21 CFR Part 11, HIPAA Compliance

Project Manager for highly regulated projects across enterprise-wide laboratory information systems.

Manage business analysts, developers, architects, and off-shore testers through Agile SDLC for the development of the following systems:

• The development of a custom regulated system called PRO that creates test results from various laboratory information systems
• PRO integrates through HL7 interfaces and web services to laboratory information systems, instruments, billing system, and reporting systems
• The development of graphical test reports that are generated and delivered through web services to Quest’s Care 360 portal for hospitals and physicians to review and download
• Led business through the vendor selection process for an Enterprise Anatomic Pathology Solution

Utilize Clarity to manage projects, budgets and for time keeping.

Agile methodology. Java, Flex, and Oracle environment.

21 CFR Part 11, HIPAA Compliance.

Managed the development of a custom laboratory information system and a web portal for clients to access test results. Project consists of receiving orders electronically, to sending test results and reports through an HL7 Interface to various EMR’s.

• Managed off-shore vendor team for development of the system.
• Worked with the business to develop business requirements and functional specifications
• Net environment
• 21 CFR Compliance and CLIA Regulations

Managed the development of a New Product that will capture ventilator data at point of care and electronically send data into hospitals electronic medical record system.

• System interfaces through HL7 interface with external systems to create an EMR record, alerts for clinicians and reporting trends for data analytics
• Responsibilities consist of managing user needs, user stories, requirements, project schedule, budget, systems hazards, and project charter
• Utilized Team Foundation Server for requirements, specifications and development iterations
• Worked with Clinicians and Focus Groups to develop current and future state workflows
• Worked with developers to design screens in Sketchflow and Silverlight
• GMP Compliant

Project managed multiple projects for the following:

• The development and implementation of a new underwriting application that was developed off-shore
• Project managed the development of an Integration layer (ESB), so Insurance Companies of the West could integrate with multiple systems
• Schemas were developed using the ACORD standard
• Responsible for setting up a new integration environment for Predictive Analytics which included setting web applications that interfaced with outside sources as well as interfacing to in-house legacy system. This integration environment consists of IBM Mainframe (Cobol, JCL, and RDBMS), SQL server, Cold Fusion, ASP, Java

Managed project schedule, risks, and budget.

Managed business analysts and testers through the development of requirements, specifications, test plans, and test cases.

Managed infrastructure and security teams for setting up servers and user security.

• Senior Project Manager, responsible for managing the setup of a disaster recovery site for LPL Financials Compliance and Order Management for Annuities System, called Blue Frog Software
• Managed in-house infrastructure team and off-shore software vendor
• Managed schedule, budget, identified risks and developed mitigation plan
• Worked closely with Chief Technology Officer

• Primary Liaison between Business units and the Technology group for the design and implementation of a new Broker Point of Sale System and a Branch Pricing Portal
• This portal interfaces directly into the Loan Origination System, MindBox Automatic Underwriting, Pricing and FileNet imaging system
• Held JAD sessions, developed requirements, and managed off-shore developers
• Managed the implementation of MindBox pricing engine
• SQL, Java and .Net environments

• Project managed the development of an Enterprise Mortgage Solution, by developing a Service Oriented Architecture which utilizes Web Services, ESB, Workflow Management (BPEL), Business Process Management, and “Best of Breed” solutions for wholesale, retail, prime, and non-prime business channels
• Managed the development of Internet and Intranet
• Project managed the in-house development and implementation of an imaging system through Agile Life Cycle
• Developed Requirements, test plans and test cases
• Project managed various vendor implementations including Pricemyloan, DISSCO for fraud, Great Plains Accounting Software, Intellimine Data Warehousing, and MindBox Automatic Underwriting and Pricing System
• Created requirements and vendor score cards
• Developed and documented the current business processes as well as “Best Practices” utilizing Proforma Corps, Provision ProcessPro Software
• Developed Software Development Life Cycle’s utilizing Agile and Waterfall methodologies
• Developed and managed budget, project plans and requirements
• SQL, Oracle, Java and .Net environments