Doannie Pagan Ocasio
Summary
Certified Project Management Professional (PMP) with 20+ years of experience leading internal and external cross-functional teams in high-profile projects within the pharmaceutical, bio-pharmaceutical, and medical device industries. Proven expertise in portfolio, program, and project management, managing multi-phase projects as part of the business strategic plan at manufacturing sites and at the enterprise level. Skilled in performing under PMI framework and Agile methodology, enabling successful initiation, planning, execution, control, and closure of projects. Experienced in defining and guiding program architecture, governance, and KPIs. Demonstrated ability to manage projects with budgets ranging from 5M to 56M. Proficient in leading the end-to-end activities for new product introduction (NPI) and commercialization, collaborating with cross-functional teams to achieve time-to-market goals. Adept at leading cross-functional teams for capital strategic projects and manufacturing site start-up, ensuring successful construction, expansion, relocation or acquisition of manufacturing facilities. Experienced in the design, procurement, installation, commissioning, validation, and implementation of highly automated manufacturing equipment. Skilled in identifying new technologies to enhance manufacturing operations. Proven track record in driving business excellence through continuous improvement and innovation projects using Lean Six Sigma methodologies. Experienced in supplier management and working with high-performance suppliers globally on contract negotiation and GMP production scale automated equipment implementation.
Innovative [Desired Position] with proven track record in managing complex programs and delivering high-impact results. Demonstrated success in leading cross-functional teams and driving project excellence. Expertise in strategic planning and stakeholder communication.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Senior R&D Program Manager
Becton Dickinson & Company
12.2021 - Current
- Delivered successful R&D projects by efficiently managing cross-functional teams and resources.
- Enhanced program performance by closely monitoring progress and implementing corrective actions when necessary.
- Recruited, placed, and oversaw project staff for optimal project results.
- Partnered with sales, strategy and business development to identify new product opportunities, manage project portfolio and work assignments.
- Worked with global cross-functional teams to gain alignment and move initiatives from product ideas to commercialization.
- Improved interdepartmental cooperation on R&D projects by fostering strong cross-functional relationships.
- Secured funding for new projects through effective proposals, presentations, and stakeholder engagement.
- Optimized resource allocation by accurately forecasting project needs and adjusting as required.
Global Supply Chain Sr. Program Manager
Edwards Lifesciences
10.2019 - Current
- Company Overview: PMO Corporate Office – Critical Care Medical Device Manufacturer - Irvine, CA
- Program Manager with global exposure and outstanding record leading Tier-1 product transfer project from conception to completion involving multiple manufacturing plants and functional departments to develop the program strategy, create the project plans and deploy the execution
- Overall project budget: 22M
- Developed business cases for the program and approval for the execution strategy
- Created project workstream breakdown and developed an integrated project schedule and high-level milestones
- Responsible, following global PMO Process, for set-up of project operating mechanisms, including (not limited to): Scorecard, Dashboard, Risk Register, Budget (CAPEX & OPEX) Tracking, Project Plan and Scheduling
- Established, maintained, and influenced stakeholder relationships, expectations, and communications, both at the local manufacturing plants and Global Supply Chain at corporate level
- Provide regular updates to management and project stakeholders and Steering Committees (Local & Executive)
- Leading and serve as a subject matter expert in project and program management to project core team composed of more than 25 Workstream Leaders, the corporate supports (RA, R&D, Labeling, Packaging, Supply Chain, Global Sourcing, etc.) and two project coordinators as a direct reporting
- Managed change in accordance with the change management process to control scope, quality, schedule, cost, and contracts
- PMO Corporate Office – Critical Care Medical Device Manufacturer - Irvine, CA
Project Management Leader
Romark Global Pharma
06.2018 - 08.2019
- Company Overview: Start-up – Pharmaceutical Manufacturer – Manatí, Puerto Rico
- Lead new site start-up project that encompassed the site construction, facility & utilities commissioning & qualification, process development, process set up, validation, stability studies, NDA submission, FDA inspection readiness, and commercialization
- Also, developed the Project Management Office (PMO) to prioritize, plan, monitor and execute the network projects
- Developed and deployed the project governance model to Puerto Rico and Belgium sites
- Implemented and led the project management process at Romark, which was nonexistence, enabling the planning and monitoring of the site and organizational projects
- Manage a cross-functional team composed of R&D, Process Development (PD), Validation Firm, Supply Chain, Quality Assurance, Regulatory among others to assure site readiness for FDA new site and product approval
- Communicated with cross-functional teams and executive management to provide visibility on the progress of projects and enables management of any constraints or risk that may induce delays
- Resolved project issues by working with team members, project customers, and other stakeholders as appropriate
- Supported remediation project for the start-up of Romark Chemical Pharmaceutical plant of API for the commercial product at Landen Belgium
- Start-up – Pharmaceutical Manufacturer – Manatí, Puerto Rico
Program/Project Manager
CooperVision Company, Inc.
01.2013 - 01.2017
- Company Overview: Medical Device Manufacturer – Juana Diaz, Puerto Rico
- Managed the planning and execution of high complexity, multiphase and high-profile engineering projects through its Life Cycle in a fast-paced fully automated manufacturing environment
- Leader for the overall project planning, execution, monitoring, reporting, capital cost estimates and control, and successful implementation of engineering projects with a capital investment budget ranged from $5.5M to $20M
- Created and layout detailed project plan with well-defined tasks, milestones, client signoff and specifications to achieve project scope using standardized management tools aligned with PMI framework
- Responsible to generate project documentation, such as project charter, project management plan and its subsidiary plans, change control, assumption and risk registers, 'scope of work', status presentation, lesson learned and project closing report
- Developed and presented the project business case, in a written and oral presentation format, to the strategic counsel and executive management to obtain project and funding authorization (Capital Expenditure Authorization, CEA)
- Sole responsible to develop, monitor and control capital project budget
- Also, conducted analysis and monitored budget to maintain 95% monthly accuracy (Company's KPI) and escalated changes and/or rollovers as required
- Communicated project progress to internal and external stakeholders at all level including executive management (i.e
- VP, CEO)
- Acted as a liaison between different suppliers to achieve equipment integration
- This included a visit to the supplier to participate in key activities such as design review, equipment construction progress, and Facility Acceptance Test (FAT)
- Evaluated and approved technical documents such as URS, FDS, FAT, SAT and validation documentation
- Coordinated and facilitated experimental studies such as clinical and product/material stability studies as well as characterization studies to evaluate the feasibility of new developed process or technology to support new products
- Medical Device Manufacturer – Juana Diaz, Puerto Rico
Sustaining Engineering Project Leader
Bard, Shannon LTD
01.2010 - 01.2013
- Company Overview: Medical Device Manufacturer – Humacao, Puerto Rico
- Led cross-functional teams in the development, transfer, and implementation of a new product, cost reduction and productivity projects
- Planned, managed, controlled and completed continuous improvement initiatives that are committed to a budget, to resolve quality events, reduce material variances, cost avoidance, regulatory commitments, and any other special projects as assigned across the plant
- Work cross-functionally project teams in Marketing, Operations, Quality, and R&D
- Provided guidance and lead process improvement and cost reduction initiatives throughout the implementation of Lean-Six Sigma techniques in Manufacturing and Engineering Departments completing three different projects within the 1-year
- Reduced material usage maximizing material consumption and minimizing the amount of wasted material (scrap)
- Achievements: Scrap reduction of 200K annualized
- Implemented project to use selective defective units for a destructive test
- Achievement: 60K cost avoidance
- Eliminated destructive test
- Achievement: 240K cost avoidance
- Lean Six Sigma Project for improving product yield
- Achievement: 214K scrap reduction annualized
- Provided coaching/mentoring on areas of expertise such as project management, six sigma, and lean manufacturing for flawless implementation of project/transfer as well as hands-on validation / technical expertise
- Worked closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of new product/change projects
- Work cross-functionally with individuals and project teams in Marketing, Operations, Quality, and Development
- Medical Device Manufacturer – Humacao, Puerto Rico
Senior Quality Assurance Specialist
Pfizer Company
01.2006 - 01.2009
- Company Overview: Pharmaceutical Manufacturer Division – Guayama, Puerto Rico
- Provided Quality Assurance support to manufacturing and final packaging operations (commercial and clinical) of solid dosages (Tablets/Capsules) packaged in several configurations
- Fully responsible for Quality System Deliverables such as Process and Equipment Validation, Periodic Re-Qualification, Engineering Change Control, Non-conformance Report, CAPA, Commitment Work-Plan, CAPAs Effectivity Check and Product Disposition, SOP approval, Master Batch Records (MBR) approval, Periodic Annual Reviews, among others
- Acting as lead investigator in collaboration with Subject Matter Experts (SME) managing non-conformance investigations, determining the scope of the investigation, developing investigation strategy, determined appropriate analytical tools required to determine root cause(s) and contributor factors and managed the resulting CAPA
- Identify required resources for the investigation
- An active member of the packaging core team responsible to approve and assure compliance of the successful implementation of new product presentations (High Speed/High Tech Packaging Line)
- Reviewed and approved all validation documents, including Cleaning Validation, Equipment Functional/Design requirements and IQ/OQ/PQ, promptly and error-free
- Active participant during FDA, DEA, TUV and many other regulatory agencies from Mexico, Japan, and China
- Internal / Corporate Audits as well as reporting the results to PPU Management
- Worked under the FDA Warning Letter environment acting as facilitator and contributor to strengthening CAPA effectiveness to conquer improvement strategy reducing 35% of the investigation reports
- Active contributor to achieving that Warning Letter status changed by FDA agency in 10 months
- Pharmaceutical Manufacturer Division – Guayama, Puerto Rico
Education
BS - Chemical Engineer
University of Puerto Rico
Mayaguez, PRMBA - Project Management
Turabo University
Gurabo, PRCertificate of Biotechnology Science -
Interamerican University of PR
J.D. - Candidate- First Year Completed
Pontifical Universidad Cótolica De Puerto Rico
Law SchoolSkills
- Injection Molding Expertise
- Solid Dosage Equipment Operation
- Ultrasonic and Laser Welding
- Automated Equipment such as Blister Thermoformed & Sealer, Capsules & Tablets Bottle Filler, Bottle Case Packer, Automated Dispensing System, Shrink Wrapping Machine, Automated Labeler and Unscramble
- N2 and UV Curing Ovens
- Parenteral Filling Process
- Proficient in HPLC
- Electrophoresis, Separation and Purification of Proteins and DNA, and Bacterial Transformation
- ESD Control and Clean Room Environment Class 1,000/10,000/100,000
- Scope management
- Problem-solving skills
- Strategic planning
- Project leadership
- Budget administration
Languages
English
Full Professional
Spanish
Native or Bilingual
Certification
- Project Management Professional (PMP) - Project Management Institute.
- Certified ScrumMaster (CSM) - Scrum Alliance.
Enterprise Systems Experience
- Microsoft Office Tools (MS Project, MS Project 365 and SharePoint)
- Program Management: Clarizen, Oracle's Instantis
- Work Management Apps (i.e. SCORO, ASANA, Podio)
- Team Comm. Apps (i.e. Teams CampFire, WebEx, GoToMeeting)
- TrackWise (CAPA, CC & NC modules)
- SAP (CAPA, Change Control and Material Management Modules)
- FactoryWork, Qumas, Master Control, Agile, Ignite, MiniTab Documentum, SCADA.
Areas Of Expertise
- Portfolio, Program and Project Management
- Design Control
- New Product Introduction (NPI) and Commercialization
- Capital Strategic Projects and Manufacturing Site Start-up
- New Technology Design/Implementation
- Business Excellence Continuous Improvement and Innovation Projects-Lean Six Sigma
- Supplier Management
Awards
- Winner of 'Team Challenge' Award of BARD Leadership Academy I & II
- Winner of Bard Principal Value of 'Continuous Improvements 2012'
Professional Development
- Project Portfolio ande Resource Management Excellence
- Certified Scrum Master, Scrum Alliance
- Project Management using Microsoft Project
Timeline
Senior R&D Program Manager
Becton Dickinson & Company
12.2021 - Current
Global Supply Chain Sr. Program Manager
Edwards Lifesciences
10.2019 - Current
Project Management Leader
Romark Global Pharma
06.2018 - 08.2019
Program/Project Manager
CooperVision Company, Inc.
01.2013 - 01.2017
Sustaining Engineering Project Leader
Bard, Shannon LTD
01.2010 - 01.2013
Senior Quality Assurance Specialist
Pfizer Company
01.2006 - 01.2009
Certificate of Biotechnology Science -
Interamerican University of PR
BS - Chemical Engineer
University of Puerto Rico
MBA - Project Management
Turabo University
J.D. - Candidate- First Year Completed
Pontifical Universidad Cótolica De Puerto Rico
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