Alison Renee Green

About Alison Renee Green

I am an accomplished Product Development Leader with extensive experience developing pharmaceutical products, including new chemical entities, product line extensions, combination products, in-licensed projects, as well as managing contract manufacturing, packaging and distribution for local and global supply needs. Proficient in matrix team leadership and hands-on development of early and late stage compounds. Scientific achievement demonstrated in aseptic processing of sterile liquids, emulsions, lyophilized and spray dried products, as well as solid oral combination tablets manufactured using wet granulation, fluid-bed drying, bilayer compression and film coating. Broad knowledge of FDA, EMA, Health Canada, ICH and cGMP regulations and guidelines. Experience in large and small pharmaceutical companies; large and small molecules. Proactive and tenacious in applying knowledge to project initiatives and communication across corporate divisions to influence and drive project teams to successful delivery of new formulations, clinical trial supplies, regulatory submissions and commercial deliverables.Key Qualifiers: Matrix team leadership, scale-up/tech transfer, validation, regulatory strategy and submissions, formulation development, due diligence, communications, and contract manufacturing.

Experience

1. Global Regulatory Affairs, Cmc Pharma

   Alcon

   Jan 2023 — Present · NC, US

Education

• University of Iowa

  Ph.D., Pharmaceutics

  1984 — 1988

• Purdue University

  B.S., Pharmacy

  1979 — 1984