Becky Moncayo Email & Phone Number

Goleta, California, Us

TMO Research and Development Program Manager for New Product Development and strategic corporate initiatives. Key Achievements:• Successfully led global cross-functional teams to launch the Rove 4 Portable Oxygen Concentrator (POC) in the US and internationally.• Leading international efforts, collaborating with third-party vendors, to secure reimbursement approvals for Germany and France.• Collaborated with TMO team to develop a best practices playbook with TMO colleagues and established a SharePoint site for efficient project information sharing among sponsors and team members.• Leading a cross-functional team to qualify as a second supplier, enhancing POC product components to reduce costs and improve quality of the productResponsibilities:• Oversee schedule management and maintain comprehensive project documentation in line with internal design control requirements and stage gate reviews.• Identify, escalate, and resolve program issues promptly to maintain project timelines.• Prepare and deliver tailored written and oral reports to internal and external stakeholders, including senior management.• Foster collaboration among cross-functional teams to achieve project milestones and deliverables, liaising with senior and executive leadership.• Leading a high-performance work environment, offering continuous feedback and mentorship to enhance team performance.• Conduct risk assessments and critical path analyses to ensure team deliverables are tracked and met effectively

Piscataway, New Jersey, Us

Senior Program Manager managing strategic business process improvement and technical projects to accelerate clinical trials and product market entry.Responsibilities:• Leading global cross-functional teams to streamline Feasibility and Site Engagement for the Life Cycle Development of Amgen products, program budget activities, and adherence to governance processes.• Building strong relationships with product teams to understand their needs and priorities.• Developing roadmaps for People, Processes, Data, and Dashboard for effective communication and cross-functional alignment.• Developing and maintaining best practices for project management, quality assurance, and key performance “KPI” metrics.• Leading the development of two dashboards to support speed to market for both Site Engagement and SEL Expansion process improvements, using lean and agile methodology. • Collaborating with business and IT to define requirements and identify optimum solution for a data repository, Salesforce.

San Diego, Ca, Us

Senior Program Management of medical device product life cycle, from Phase 0 to launch, of new In Vitro Diagnostics (IVD) platforms and assays. Responsibilities:• Led cross functional project teams (Finance, Regulatory, R&D, Clinical, Supply Chain, Legal, Marketing, Manufacturing, Process Engineering, QA, QC, Packaging, and Biostats) to develop project and communication plans, resource allocations, and budgets to align with the overall program strategy.• Worked closely with Regulatory and Marketing developing commercialization deliverables.• Led Leadership team (Portfolio, Finance, R&D, Manufacturing, and Marketing) to identify product to on a newly built $50M manufacturing line.• Successfully launched In Vitro Diagnostics Product into US and EU markets with 510(k), 21 CFR Part 820 guidance, CE, IVDR, and IVDD clearance of the Sofia 2 Campylobacter FIA test and Sofia 2 C. difficile FIA test.• Implemented Planisware as a Portfolio and Project Management tool, integrating with SAP S4/hana, leading pilot for budget/LE updates for PMO projects.• Collaborated with Head of Program Management & Operational Excellence and Functional Leads for formal presentations/communications for monthly update to Senior management.• Conducted quality assurance evaluations of products effectiveness, gathering feedback from stakeholders and making recommendations for continuous improvement.• Worked with the Business to develop milestones and KPI metrics to develop high-level road maps, detailed project plans to track progress, and communicate program progress.• Developed new team members on assays, GCPs, processes, and systems (Windchill, Azure, Jira, and Planisware).

Charlotte, Nc, Us

Senior level Project Manager's and Agile Team lead responsible for the upgrade of the bank’s MSP system and data conversion, $500M project. Responsibilities: • Led activities to upgrade bank’s MSP system and data conversion ensuring processes are followed, required documents were completed, and required tracking systems were kept up to date.• Partnered with stakeholders to clearly define desired outcomes for new project requests, working with product owners to translate those requests into a prioritized backlog that maximizes business value, and providing direction and feature/user story guidance to the development teams on behalf of stakeholders.• Conducted risk management and scenario planning, developing contingency and/or risk mitigation plans.• Established and managed milestones, metrics, and prioritized backlogs, ensuring effective progress towards project completion.

• Provided over $23M Residential Real Estate services for individuals and families buying or selling real estate. • Extensive Project Management, Negotiation, Risk Management, Change Management, and Communication skills while working with contractors, architects, city planning, lenders, escrow, title, homeowner associations, legal, tenants and US District Attorney to ensure successful close of escrow.

Foster City, Ca, Us

Senior Project Manager for the move of the San Dimas manufacturing plant resources and processes to the new La Verne plant.Responsibilities: • Managed the move of the San Dimas manufacturing plant resources and processes to the new La Verne plant.

Geneva, Switzerland, Ch

Project managed the commercialization and launch of two key medical device products for Intra Ocular Lens products.Responsibilities: • Project managed a cross-functional team (R&D, Finance, Corporate / Regional Legal, Medical Affairs, Market Research and Market branding venders) for regional product launch of Clareon® IOL and aligned product launches to generate optimum revenue.

Thousand Oaks, Ca, Us

Sr Project Manager / BiotechProject Managed the implementation of a validated Chemical and Reagent Inventory System. Responsibilities: • Managed a global cross functional team which included Leadership, R&D, Finance, Health and Environmental Services, to implement a Chemical and Reagent Inventory Management system using Biovia's CISPro solution to provide a single solution for chemical procurement, generate compliance reports for inventory levels to regulatory authorities, and manage chemical inventory.• Worked with Leadership to prioritize the project, create business case financial models, road maps, project plan(s), managed resources to expand services and potential business opportunities.• Led the implementation of a Datamart for compliance reporting of chemical inventory level (HMIS, Tier II, SARA 313, and Explosive Reports).• Monitored project scope, schedule and costs to ensure all remain on track with the contract and with financial performance targets. Initiate and implement appropriate actions to proactively manage the change control process both internally and externally.Moncayo Realty, California 08/08 – 08/19Broker Owner/Program Manager• Extensive experience in program management, negotiation, risk management, change management, and communication.• Successfully sold over $23,100,000 worth of properties between 2009-2015.

Thousand Oaks, Ca, Us

Sr. Project Manager and Dev IS Manager / BiotechManaged a team of project managers and business analysts for projects for programs/projects supporting Global Regulatory Affairs and Safety. Additional achievements include the implementation of a Global Data Warehouse and a Laboratory Information system. Responsibilities:• Project managed a variety of global projects ranging in scope from business process analysis to full system implementation across departments, time zones, and continents to support product commercialization• Led a multi-disciplined team in the delivery of small to large, complex business and technology solutions.• Provided service excellence by identifying key client business issues, determined client needs by supplementing the standard assessment techniques and tools with innovative approaches, evaluating and validating analysis and developing recommendations for clients.• Developed strategies, policies and tools for a Project Portfolio Financial Review Process, Workforce Management Review, and Budget Review.• Partnered with Leadership, Medical Affairs, Global Safety, Compliance, and Regulatory Affairs to identify and implement various projects, programs and plans to support business unit enterprise goals.

Mba, Business

Education record

Ba, Is

Electrical And Electronics Engineering