Quotient Sciences’ facilities in Garnet Valley and Boothwyn are located just outside of Philadelphia.
Together, the facilities support small-molecule oral solid dose (OSD) formulation development and drug product manufacturing, with capabilities for small batches for Phase I/II trials through late-phase manufacturing and commercial product supply.
As part of recent site leadership appointments, Nichole Caparelli has joined the company as Sr. Director, Quality Operations. Ms. Caparelli has over two decades of experience in quality and operations roles with companies including Johnson Matthey, Veranova, and Flamma Group. Marlene Leuenberger has also recently joined as Vice President and General Manager of Quotient Sciences’ Philadelphia facilities.
In this interview, Nichole discusses her new role and enhancements at Quotient Sciences – Philadelphia that focus on quality.
Tell us about yourself and your background.
My career has been focused on small molecule manufacturing, including product development through commercialization. At past organizations, I have been responsible for implementing and overseeing quality management systems and driving continuous improvement initiatives that enhance overall product and process quality and operational efficiency. This involved successfully leading regulatory authority inspections and ensuring quality management systems are in place, in use, and effectively monitored to facilitate compliance with cGMP requirements. Most recently, I was a Quality Director at Flamma USA, leading the QA, QC and stability teams in the development and implementation of comprehensive quality management systems.
What initially got you interested in a career in Pharma?
My choice to pursue a career in pharmaceuticals was driven by my desire to make a tangible difference in people’s lives and my admiration for the complexity and innovation inherent in the industry. I am eager to contribute my skills and knowledge to a field that holds such profound significance for global health.
What will your role focus on at Quotient Sciences – Philadelphia?
In my new role, I report into our global quality department and will be responsible specifically for the Quotient Sciences – Philadelphia sites. This involves leading the quality system, project quality assurance, and quality control functions at both of our Philadelphia facilities.
What developments are on the horizon this year to enhance quality and related systems or processes at Quotient Sciences – Philadelphia?
For 2024, we are focused on continuing to build Philadelphia's overall site quality culture. This will be done largely through continuous improvement and a focus on the people, processes, and systems for quality. I will be leading the site quality operations team to consistently achieve compliance targets and aid in transforming the site's approach to quality.
Learn more about Quotient Science's facilities in Boothwyn, PA and Garnet Valley, PA.