Overview

Gender

male

Brent Golec is the Executive Director, Pharmaceutical Development at Ionis Pharmaceuticals, has more than 21 years of experience in formulation development, process engineering, and GMP manufacturing of oral and parenteral dosage forms. His expertise includes aseptic manufacturing, lyophilization, and prefilled syringe technologies.

In his role at Ionis, Mr. Golec has provided real-time resolution of GMP drug product manufacturing issues, selected and managed CDMOs, employed quality engineering principles to enhance the oligonucleotide drug product manufacturing process, and was a main contributor in establishing Ionis’ combination product development process. Additionally at Ionis he has led and provided strategic direction for the development of the prefilled syringe commercial dosage form for Volanesorsen. Previously, Mr. Golec served as Principal Scientist, Head of Formulation Development at Anadys Pharmaceuticals. There, his responsibilities included designing and executing solid dosage formulation and GMP manufacturing strategies, as well as developing oral suspension formulations. From 2005 to 2007, Mr. Golec served as Process Engineer at Amylin, where his work on Bydureon™ included leading the CMC prefilled syringe project sub-team for the Amylin/Alkermes/Lilly Alliance and designing, scaling up the commercial manufacturing process, along with engineering support for design/construction of the Amylin Ohio sterile microsphere production facility. From 1999 to 2005 as Senior Scientist for Pfizer Global Research and Development, he led the development and GMP manufacturing of both parenteral and solid oral dosage formulations. From 1995 to 1999, he was part of a research team that created innovated tissue targeted ultrasound imaging agents for injection. From 1994 to 1995, Mr. Golec worked in the field of DNA technology.

Mr. Golec received a B.S. in Biochemistry and Cell Biology from the University of California, San Diego in 1994.