Managing Consultant with 35+ years of technical and business experience; 15 years in medical devices, 20 years in Vaccines/Pharmaceuticals, and 18 years in contract management. Results-oriented program leader with proven strategic, product/ program, and stakeholder communication management skills. Experienced managing multi-functional teams, that include subcontractor and business partners; driving medical device, drug, and biologic products through development and global commercialization. Provided strategic planning to align short and long term product supply with market demand, obtained stakeholder commitment and developed targeted metrics to assess product performance. Demonstrated ability to build product portfolios to expand existing market share, enter into new markets, or through product improvements. Able to interface with all stakeholders internally or externally to obtain new ideas, resolve issues, implement process improvement, set expectations, and adjust planning based on metrics. Direct experience in internal and virtual product development and operations covering all aspects of the product and analytical development cycle from R&D, pilot, technology transfer, scale-up, validation, full scale operations, licensure, and global supply chain. Evaluated new business opportunities, acquired new capacities, transferred technologies, formed partnerships, and developed communication and implementation plans for effective integration.Specialties: Vaccine/Drug and medical device product and process planning, development, technology transfer, manufacturing scale up, validation, and commercialization. Portfolio, program, and project management. Acquisitions/ mergers due diligence, integration planning and execution. Contract compliance and technical oversight.
Listed skills include Fda, Technology Transfer, Validation, Biotechnology, and 44 others.