Regina Ali

About Regina Ali

I have several years’ experience synthesizing, growing, harvesting, purifying, and analyzing oligonucleotides, small molecules, and biologics from diverse expression systems including mammalian cells, Pichia, and plants. My experience encompasses process development, project management, production scheduling, documentation, compliance, and change control management for and L drug substance cell culture, purification, drug product parenteral fill, oral solid dose, and oligonucleotide synthesis facilities. While working full time in biopharmaceutical manufacturing and fill finish, I earned an MBA and PMP to integrate business acumen into my competencies. Specialties: Mentor and advocate for biopharmaceutical manufacturing, process development and change implementation, 6Sigma methodology, technical transfer, business process mapping, project management and metrics development. Supply chain production planning and material reconciliation.

Experience

1. Lead Clinical Supply Manager

   Biogen

   Feb 2024 — Present

Education

• North Carolina State University

  BS, Biological Sciences

  1989 — 1993

• North Carolina State University

  BS, Biochemistry

  1989 — 1993

• Clemson University

  MS, Environmental Toxicology

  1994 — 1998

• North Carolina State University

  Master of Business Administration - MBA

  2014 — 2017