Leigha R. Dolcemascolo

About Leigha R. Dolcemascolo

As a Senior Process Expert at Novartis, I serve as the Subject Matter Expert for all products at the world’s first multi-product CAR-T manufacturing site, providing critical front-line support for process issues, a commitment fundamentally rooted in a patient-centric mindset. This perspective transforms my role from a technical function into one of direct responsibility for patient outcomes, ensuring that every operational decision I make, from quality system management to process optimization, is driven by the need for product safety, efficacy, and timely delivery. I actively lead, own, and drive the resolution of critical quality events, including comprehensive Deviation Investigations, CAPAs, and Quality Events. I ensure that investigations are robust, root-cause analyses designed to implementing long-term preventive measures. I treat every single event with the highest degree of urgency and thoroughness, understanding that any delay or error directly impacts the patient.A significant portion of my effectiveness is derived from my ability to champion unified relationships and seamless collaboration across diverse internal and external stakeholders. I serve as the Process Excellence representative in all major cross-functional teams and GXP problem resolution forums. This requires expert communication to balance the technical needs of Manufacturing. Specifically, I manage complex process issues and facilitate real-time triage in a cross-functional group to ensure swift, compliant decision-making for multi-product operations. Externally, I ensure consistent processes and communications across Novartis and with external CMO Partners, upholding product consistency regardless of the manufacturing site.My experience extends to hands-on operational leadership. As a Cell Processing Team Ad Interim Supervisor, I provided mentorship, guidance, and direct support to a multi-operational and multi-functional team. I was responsible for overseeing the scheduling and execution of all production operations. I encouraged team members to contribute their ideas and fully participate in these improvement projects, creating a highly engaged and accountable workforce.Ultimately, my expertise in operational excellence, quality system management, and cross-functional leadership is channeled towards one singular, non-negotiable goal: ensuring a reliable, consistent, and high-quality CAR-T product delivery that has the power to change and save lives. My work provides the operational integrity necessary to fulfill the promise of cell therapy for patients globally.

Experience

1. Senior Process Expert

   諾華公司

   Sep 2025 — Present · Morris Plains, NJ, US

Education

• Marywood University

  Masters of Science, Biotechnology

  2014 — 2016

• Marywood University

  Bachelor of Science - BS, Biology/Biological Sciences, General

  2010 — 2014