Area of Expertise:
Heather provides regulatory affairs; chemistry, manufacturing, and controls (CMC); and technical support to companies developing drugs, biologics, and combination products. She is experienced in regulatory writing and submission support, integrated project management, and development and implementation of regulatory CMC strategies for products in various phases of development in global markets. Heather also has experience reviewing and developing Quality Systems and performing Quality Assurance (QA) functions such as coordinating or performing quality or complaint investigations, batch record review, and manufacturing change control management and performing compliance audits. Additionally, Heather is experienced in project management for integrated product development programs. Heather has a B.S. in Chemical Engineering with a concentration in Biomedical Engineering from Cornell University and has been a member of the SciLucent team since 2013.