Sr Program Manager

Catalent Pharma Solutions; Princeton (NJ); On-site; USD 160,000 - 170,000; Full time

Benefits offered by this job

PTO & holidays

Medical/Dental/Vision on Day 1

Tuition Reimbursement

Green initiatives

Job summary

Catalent, Inc. in Princeton, NJ, seeks a Sr Program Manager to lead quality systems programs including Deviation, CAPA, and Change Control. You will manage investigations, risk assessments, and effectiveness checks, and serve as site SME for quality compliance and continuous improvement.

This role requires strong cross‑functional leadership in a regulated cell therapy environment. Expect collaboration across QA, Manufacturing, and Regulatory teams, ensuring timely milestones, audits, and

Qualifications

• 7+ years of direct experience in project management and/or pharmaceutical industry.
• Bachelor’s degree in science or engineering; advanced degree preferred.
• PM certification (PMP) or related coursework preferred.
• Working knowledge of biologics fermentation, cell culture, purification and analytics.

Responsibilities

• Lead Deviation, CAPA, and Change Control programs to ensure regulatory and quality compliance.
• Manage investigations, risk assessments, root cause analysis, and effectiveness checks.
• Serve as site SME for Quality Systems and drive continuous improvement initiatives.
• Monitor quality metrics and drive cross‑functional governance for timely issue resolution.
• Support regulatory inspections, customer audits, and internal audits.

Skills

Project management

Regulatory compliance

Cross-functional leadership

Quality systems

Biologics knowledge

Education

Bachelor of Science in Science or Engineering

Master of Science / MBA preferred

PMP Certification preferred

Job description

Position Summary

Sr Program Manager Position Summary: Shift: M-F 8am-5pm Location: Princeton, NJ 100% Onsite 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. The Role 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.

Candidate Minimum Requirements

Bachelor of Science in Science or Engineering, or equivalent combination of education and experience required. Advanced degree (Master of Science, Master of Business Administration, Doctor of Philosophy) is preferred. Approximately 7+ years of direct experience in project management and/or pharmaceutical industry. 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.

Preferred Skills & Background

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.

Pay

Pay The anticipated salary range for this position in NJ is $160,000 – $170,000 Plus Bonus. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Benefits

• Competitive paid time off plus 8 paid holidays
• Community engagement and green initiatives
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement

Why You Should Join Catalent

Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Competitive paid time off plus 8 paid holidays Community engagement and green initiatives Medical, dental and vision benefits effective day one of employment Tuition Reimbursement Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities.

Equal Opportunity Employer

Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Company Overview

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life‑cycle supply. With time-tested experience in development sciences, delivery technologies, and multi‑modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.