• Facilitated and drive functional planning for new product launch plans. • Developed and Supported budgeting process for the new product Launch • Developed project timelines – identify gaps, risks and priorities.• Led multi-functional planning and tracking for commercial launch plan activities for an upcoming biopharmaceutical product launch. Design strategic workforce plans• Built and managed critical path schedule to ensure timely execution of project plans. • Identified priorities, and help understand and identify dependencies across plan deliverables • Single point of contact for understanding and managing project timelines. Provided clarity and alignment to plan and drives accountability within team.• Managed and communicate change to initiative timing and scope • Assist launch team with identifying any key gaps, risks, or opportunities related to launch activities and coordinate risk mitigation plans• Provided recommendation improvements to project plans and different scenario planning• Ensured that the program measures were defined, regularly tracked and reported to the leadership• Supported Ad hoc projects

• Facilitated and drive functional planning for existing product and pipeline opportunities. • Developed and Supported budgeting process for the Medical Affairs Initiatives Disease Program• Developed Launch Program and Tactics Initiatives, Launch readiness, Program Strategy and Medical Affairs initiatives with US, Global and International• Ensured seamless implementation of Medical Affairs strategic plan.• Led the tactics for Medical Affairs congressional presence, thought leader engagement logistics, medical advisory boards and other Medical Affairs initiatives. • Vendor management and responsible for ensuring budget is on track and properly documented. • Built outstanding partnerships with all the cross-functional teams to execute a successful launch of assigned products• Work closely with external benchmark, bring improvements to optimize launch planning, implementation and processes.• Supported the product launch team when influence and negotiation is required.• Supported inspection readiness and ensure appropriate compliance policies are in place.Launch Excellence

Consultant, responsible for review & implementation of Validation Lifecycle approach for GMP Facility.• Developed & reviewed Validation Lifecycle documents GMP equipment, facilities, & utilities.• Coordinated development, process engineering & manufacturing of aseptic fill & finish projects.• Provided QA oversight for project preventive maintenance program in SAP.• Coordinated & provided input & requirements for filling equipment, cleanroom HVAC & utilities.• Developed & implemented quality management systems for contract manufacturing supplier.• Led Gap Assessment to Preventive Maintenance & Engineering program.• Developed & managed Annual Product Review for various products, drove completion first drug commercial product for Oncology Therapeutic area.

Consultant, responsible for implementation & oversight of manufacturing practice & PM program. • Provided QA oversight to SAP project preventive maintenance programs.• Coordinated & provided input & requirements for filling equipment, clean-room, HVAC & utilities.• Managed cross-functional teams - Validation, Engineering, Quality, Manufacturing, Training & Document Control.• Performed Gap Assessment to Preventive Maintenance & Engineering program. • Aligned procedure to maintenance manuals recommendation.• Align engineering maintenance procedure to operating manuals, FDA guidance & cGMP.

Consultant, responsible for review & implementation of Validation Lifecycle approach for GMP Facility.• Developed Program Management Plan and drove completion first drug commercial product for Oncology Therapeutic area.

Project Management Consultant, led engineering remediation & GAP assessment.• Led engineering & facilities upgrades for OTC drug manufacturing.• Managed cross-functional teams - Validation, Engineering, Quality, Manufacturing, Training, & Document Control, through remediation projects activities.• Implemented knowledge of FDA Regulations for pharmaceutical manufacturing, CFR 210 & 211. • Led impacts assessment for remediation activities, identified risks & established contingency plan. • Identified & coordinated capital projects initiative & aligned priorities with site expectations. • Aligned Engineering Department to GES, FDA guidance / requirements & cGMP. Developed Capital Program Long Range Plan for site.

• Led Implementation of PMO best practices & Launch Excellence• Planned & managed programs of significant complexity with full responsibility of financial aspects.• Managed $50MM+ budget.• Led GMA Programs Strategy & tactic for 5 Therapeutics areas with $50MM+ budget - Rare Diseases, Nephrology, Biosurgery, Cardio, Immunology & Inflammation.• Developed long range $80MM capital initiative.• Led implementation of multiple applications within organization.• Harmonized project management tools with significant international exposure.• Managed budget for new drug development.• Identified needs & provided recommendations to SVP, Head of Global SCD & Nephrology, Immunology, Inflammation, Cardio, Biosurgery Medical Affairs, supported achievement of global strategy & PCS KPI goals & responded to changing priorities.• Collaborated with Global Medical Affairs, developed long-term strategy to realize GMA vision for products & aligned plans with organizational budgets.• Increased efficiency & maximized product synergy assessed internal GMA processes.• Developed & executed cross-functional & global strategic plans.• Led training of 4M/ZINC online tool - Medico, Marketing, Material & Management, NEXTS, Catalyst.• Reduced organization expenses identified & hired different vendors. • Developed budget & forecasted with Finance & other stakeholders, led LRP Process.Led e-room & SharePoint efforts for SCD organization, harmonized internal process, implement business best practice, consolidate budget.• Developed dashboard for the visibility of the financials aspect across every Therapeutics area.

Senior Project Manager - Genzyme a Sanofi Company, led Quality Programs for Consent Decree. • Led cross functional team Micro/Chemistry Lab, QC, QA, Regulatory, Manufacturing, Engineering, Validation, Document Control, Training, PMO, Third Party-Quantic.• Managed Laboratory Equipment Qualification Program & Process Validation Program.• Developed full master scale project plan, utilized Microsoft Project & forecasted budget.• Implemented & managed project changes & interventions, achieved project outputs.• Led budget review & forecasted budget for department, worked closely with Finance Department.• Led Standards Gap Analysis & implemented required actions aligned to standards. • Led Risk Assessments, implemented mitigation actions. • Purchased instrument & supplies for new labs & hired employees, temps & contractors.• Program manager for the most complex, visible programs, responsible for strategic sourcing to long-range planning & execution.

Provided direct input to support cross-functional teams, assuring projects are managed in accordance with appropriate technical project management procedures and corporate standards for engineering and validation. Project teams typically draw members from Project Management, Automation, Development, Engineering, Facilities, Operations, Quality, Regulatory Affairs, and Validation functions.Aligns site procedures for technical content, engineering, and validation with industry best practice benchmarks and provides input to corporate standards. Supports project goals and ensures that delivered results meet process and user needs. Encourages the use of risk-based tools for prioritization and decision-making across the project lifecycle, from need identification through design and commissioning to implementation. Provides final quality approval of project and technical documents, including requirements specifications, engineering drawings, project plans, commissioning, qualification, and validation documents.Developed and delivers quality and technical training to departmental staff and project teams.Fosters a positive working environment. Actively develops group knowledge and capabilities

Industrial Engineer, led complex engineering & management systems projects.• Identified deficiencies in production, supported activities & recommended corrective action. • Coordinated with SAP system & planned production activities. • Developed system documentation, user instructions & procedures, implemented actions & assisted training activities.• Increased department efficiency, coordinated & implemented Six Sigma & Lean Event projects.• Implemented & trained personnel on Logistic Modernization Program & SAP software.• Organized & harmonized Bill of Materials & engineering drawings.

Validation Project Manager & RCCV (Regulatory Compliance, Commissioning & Validation) Consultant.- Managed different client in the Pharmaceutical/ Biotech Industry as Chiron, BMS, Eli Lilly, Abbott, Pfizer, Pharmacia, Searle and GSK. Among different location PR, US and EU. During one project assignment managed and led team up to 60 resources. Coordinated and Implemented Validation Life cycle: URS, DS, DQ, IQ,OQ, PQ and PV protocols preparation, execution and report for Computer Systems, (DCS, Delta V, PLC, LIMS), equipment, facilities, utilities and manufacturing processes, including reports. Coordinated and aligned activities for IQ,OQ,PQ protocols preparation, execution, and report for control systems., equipment and facilities.Managed start-up and commissioning packages execution and coordination. Developed, reviewed, and close CAPA deviations reports, amendments, and addendum documents. ● Responsible for preparing weekly status reports for senior upper management.● Conducted client’s communication sessions to evaluate client needs & ensure timely project delivery.● Coordinated & scheduled training programs to employees in order to help them acquire advance skills and thereby enhancing productivity.● Developed Proposal in response to RFP. Negotiation skills.● Proficient in building and managing client relationship, including negotiating and administering contracts, deliverable and project statement.● Project control, controlling cost and improving efficiencies.● Coordinate and align activities within the project life cycle.

Managed validation team for the Barber Colman Building Monitoring System (BMS). Developed Validation Master Plan, Functional Specification and User Requirement documents for the BMS. Reviewed and approved validation protocols development IQ, OQ, Coordinated protocols execution strategy. Reviewed Final Summary Reports. Accomplished clients goals and expectations. Act as Validation Project Manager for the Celecoxib Project Bulk Pharmaceutical Production Facility Managed DCS (Distributed Control System ). Developed protocol (IQ,OQ & PQ) and coordinated execution strategy. Motivated team to achieve deadlines in a short time frame. Validated the manufacturing process, process equipment and process for a 320 MT capacity increase (100% increase) for the Pharmacia Celebrex production train. Provided technical support to engineering and process control support to plant operations and on-site troubleshooting for process equipment and DCS. Coordinated and performed P&ID walk downs on process equipment and utilities. Implemented Project Management philosophy and GAMP standards in the project life cycle.