Leslie Wolfe

WORK HISTORY

EDUCATION

SKILLS

ABOUT LESLIE WOLFE

I have experience in the biotechnology business with a focus on CMC activities including process development, analytical development, manufacturing and regulatory compliance with cell and gene therapy products.My most recent job was at Generation Bio: Manage and built a team of scientists engaged in the manufacturing of a novel DNA genetherapy product for non-clinical/animal studies. Oversees the project work of 30+ scientists in upstream and downstream processdevelopment to build research scale and scale-up procedures using both cell and non-cell based (enzymatic synthesis) processes. Manage the Analytical Development team to establish testing programs for both the drugsubstance and drug product using lipid nanoparticle delivery systems. Supervising efforts of external vendors working on drug substance and drug productformulations for non-clinical and clinical phases. Responsible for the compliance of these efforts. Completed FDA submission for the CMC sections of an INTERACT (pre-preIND) review.