Over 15 years of experience in Supply Chain, Clinical Supplies, Manufacturing, Packaging, and Quality; strong leadership experience with large and small teams; well versed in cGMP requirements for commercial drug supplies and R&D/Clinical supplies; ASQ Certified Six Sigma Green Belt; Project Management Professional (PMP) Certified; Experienced in: New Product launches; CMC requirements for New Drug Applications, and EU Market Applications; contract manufacturing and packaging of commercial and clinical supplies management; packaging and shipping qualifications, process validations, product tech transfers, and cold chain solutions; supply chain planning, production planning, forecasting, and product distribution; FDA, EMEA and MHRA site audits; contract review and negotiations.
Project Manager offering 15+ years of experience in regulated life sciences industry. Direct experience in gene therapy and large and small molecules projects. Proven ability to manage external and internal business partners to achieve project objectives including scheduling, budget control, product quality, and cost reductions. Hands-on experience in product development (Pre-clinical through Phase III clinical trials) and commercialization. Proficient in GXP regulations and international standards. Certified Project and Program Management with strong scientific background.
17 years of clinical supply chain management experience including Quality Assurance; strong understanding of regulatory requirements (cGMP and Annex 13); ability to work independently and proactively on multiple projects under tight timelines; effective team member who collaborates and shares information with others; strong work ethic consists of attention to details, quality and integrity of work performed.