Sr Program Manager

Catalent•Princeton, NJ

8d•Onsite

About The Position

Catalent’s Princeton, New Jersey site is a key part of the company’s cell therapy network and serves as a U.S. commercial manufacturing facility for autologous and allogeneic cell therapies. The site is equipped to support the full product lifecycle, including late‑stage clinical development, process characterization, and commercial‑scale CGMP manufacturing across a wide range of cell types. With flexible cleanroom suites, quality control laboratories, and an experienced technical team focused on scalable, single‑use manufacturing approaches, the Princeton site enables reliable production and supply of advanced cell‑based therapies. As part of Catalent’s global Cell & Gene Therapy organization, the Princeton facility plays a strategic role in helping partners advance complex, personalized medicines toward commercialization. We have an opportunity for a Sr Program Manager to join our team and deliver on program objectives within agreed timelines, budgets, and quality standards. In this role, you will apply strong project management practices and lead cross-functional teams to achieve success. You will maintain open communication with clients, provide updates, and ensure milestones are met. This position requires a solutions-oriented mindset and the ability to adapt in a dynamic environment.

Requirements

Bachelor of Science in Science or Engineering, or equivalent combination of education and experience required.
Approximately 7+ years of direct experience in project management and/or pharmaceutical industry.

Nice To Haves

Advanced degree (Master of Science, Master of Business Administration, Doctor of Philosophy) is preferred.
Project Management Professional or Project Management certification or coursework preferred.
Working knowledge of Biologics Fermentation, Cell Culture, Purification and Analytics preferred.
Professional experience in a related field such as Biologics, Biotechnology, or Pharma preferred.
Experience working across Catalent sites preferred.
Experience managing commercial programs preferred.

Responsibilities

Lead and oversee Deviation, CAPA, and Change Control programs to ensure compliance with regulatory requirements, quality standards, and customer expectations.
Manage the full lifecycle of investigations, CAPAs, and change controls, including risk assessments, root cause analysis, impact evaluations, and effectiveness checks.
Serve as the site Subject Matter Expert for Quality Systems, providing guidance, training, and support on compliance, investigations, and continuous improvement initiatives.
Monitor quality metrics and trends, drive process improvements, and lead cross-functional governance forums to ensure accountability and timely resolution of issues.
Support regulatory inspections, customer audits, and internal audits while fostering a culture of quality, compliance, and operational excellence.