Stephanie Colotti

About Stephanie

Stephanie serves as Senior Partner at Validant. With over 30 years of pharmaceutical and biotechnology industry experience, Stephanie brings Quality, Regulatory and Aseptic Manufacturing Operations expertise to her role. She most recently worked at Promega Corporation, the largest privately held biotechnology company in the world. There, she served as the lead cGMP technical program manager specializing in capital equipment and design control projects. She was also Promega’s internal resource for Lean/Six Sigma initiatives.  Stephanie led the fabrication and installation program for two fully cGMP compliant RABS fill/finish manufacturing lines.  One was a bottle/vial fill/finishing line while the other was a cartridge fill/finish line.  She also led a new product introduction program for the first cGMP compliant DNA purification system marketed by Promega.  The Maxwell® system is comprised of a software controlled instrument, disposables and reagents working together to provide reliable and rapid DNA purification from patient fluid or tissue samples.

Prior to joining Validant Stephanie worked in the areas of new product introduction, project management, process and product validation and quality for Baxter Healthcare for more than 20 years.  There she had leadership responsibility for two of Baxter’s Top Five projects.  One was a multi-million dollar barrier isolator installation that manufactured a lyophilized plasma-based hemophilia product.  The second was a $40 million barrier isolator pre-filled syringe platform utilizing in-line ebeam sterilization technology.  Previously, Stephanie led several critical clean room installations and qualifications at various Baxter sites.  She has led manufacturing expansions and Greenfield projects.  Stephanie is an expert in aseptic parenteral solution manufacturing, specifically in the areas of formulation, fill and finishing operations.

Stephanie earned a Bachelor of Science Health Care Management from Southern Illinois University and an MBA from Delta State University.