Director, Launch Operations, Global Manufacturing Services
New York, New York, Us
Lead team to industrialize new pharmaceutical products, providing product knowledge and expertise on process capability, manufacturing and asset maximization to accelerate global commercialization of new products from GMP compliant manufacturing facilities.• Lead new oncology product teams to develop and execute plans for technology transfer, registration batch manufacturing, process validation, and global commercial launch. Project scope includes $10-20 million budget over 3-5 years to engineer a commercial formulation, transfer and scale-up the formulation to a GMP compliant manufacturing facility, ensure manufacturing robustness, supply late stage clinical supplies, ensure facility readiness for FDA, EU and PMDA facility inspections, validate and commercially launch the new product.• Received 2008 President’s Achieving Excellence Award for finalizing commercial formulation and process at the commercial manufacturing site prior to initiating Phase 3 studies, reducing costs and regulatory risks associated with conducting bioequivalence studies to demonstrate product equivalence between different formulations manufactured at different sites.• Conducted sourcing exercises by selecting a commercial manufacturing site, based on quality and GMP requirements, capacity and demand analyses, and projected cost of goods.• Reduced cost of goods by incorporating lean concepts, including process analytical technology, to ensure manufacturability and cost-effective.• Determined product and package trade dress, minimizing SKUs and standardizing formats to reduce global costs.• Represented organization in due diligence for licensing opportunities.
