Uniquely qualified and positioned Product – Value – Solutions-Driven Senior Executive in Development, Manufacturing, CMC submissions, QS integration, Operations, Strategic Planning Experienced, Accomplished, Persevering Leader of Startup and Commercial Development, and Manufacturing Enterprises Noted Success Developing People and Organizations and Instilling Focus In Many Companies Unique in ability to find novel solutions to complex problems in management and cutting edge technologies Thriving career as catalyst in cutting edge development of new biotech products — timely, cost-effectively, within regulatory constraints Reputation for meeting challenging roles under critical circumstances to ensure company survival and promote commercial viability of products, and creating new processing paradigms-30 year biotechnology professional in development, manufacturing, quality systems, logistics and planning, facility operations and CMC for FDA and EU regulated products.-Experienced in protein based and small molecule/peptide parenterals, cell and tissue therapy, and biologic/device combination products.-Corporate senior manager for biotechnology and small molecule industry well founded in strategic planning, tactical execution, project management and associated budgeting and focused on areas adding value.Specialties: · Manufacturing, QS, Project Management· Product, process, method, & manufacturing development, validations· Budget development & oversight· Supplier contracts, license agreements· Materials, purchasing, logistics, shipping· Due Diligence· CMC submissions· Quality System development and integration· Product performance, reliability, characterization· Facility design, construction, and validation· Risk identification and mitigation – product and corporate· Staff building
Listed skills include Biotechnology, Fda, Biopharmaceuticals, Validation, and 27 others.
