I am a strategic project Leader with 20+ years’ experience in project management and pharmaceutical and drug-device combination development leading global cross-functional teams E2E, internally and externally (CROs, CDMOs and Tech Ops). I am recognized as a strong team player, relied upon to raise important issues, develop innovative methods for resolving problems, and enhance the team’s capacity to consider the big picture. Specialties: Project Management, Team/Project Leadership, Third Party Management, Operational Excellence, Stakeholder Management, Formulation/Process Development, Resource Management, Technology Transfer, CMC Development, Risk Management, CMC Regulatory, Ophthalmic formulationsExperience:Project/Portfolio management • Implemented new product introduction process and long-term strategic capacity/capability planning for small molecules, biologics and cell and gene therapy products clinical supplies manufacture at Pilot Plant Aseptics. Evaluated 15 projects/3 platforms with 8 deemed a good fit and implemented them within 12 months.• Oversight of third parties, managing a portfolio of over 40 vendors ensuring adherence to business and quality standards with over 95% vendor compliance rate and consistently delivering on project milestones.CMC Development• Led development plan for Cell and Gene Therapy support projects, external manufacturing and clinical DP batch release ensuring ontime in full delivery and initiation of Clinical trials.• Oversight of development from early preclinical to product launch for several ophtha and otic products. Achieved market success for six Ophthalmic and Otic products.• Developed liquid, semi-solid and solid dosage forms. Holder of six patents.• Oversight/authored/reviewed CMC sections to major and minor regulatory filings across multiple jurisdictions.• CMC technical regulatory input to Health Authorities agencies, achieving 100% on-time delivery.• Coordinated Risk Management Review (RMRs) for medical devices with 100% renewed life cycle management. Operational Excellence• Designed a tool to collect, assess and prioritize continuous improvement ideas for Technical R&D. Submitted 65 ideas, with 36 progressing to six sigma projects and simplification ideas.• Organized Six Sigma basic training and achieved more than 90% of associates, in line unit, trained.• Coached two Six Sigma Green Belt projects and two Six Sigma Yellow Belt Project certifications.• Ensured achievement of KQI/KPIs for Manufacturing site and Global Pharmaceutical Line Unit.