Clinical Production Specialist

Clinical Production Specialist

Catalent's Philadelphia, Pennsylvania site serves as the company's North American Center of Excellence for clinical supply packaging, delivering comprehensive, end‑to‑end support for global clinical trials across multiple therapeutic modalities. The site provides integrated services including direct comparator sourcing, blinding and manufacturing, primary and secondary packaging, storage and distribution, and clinical returns management, enabling efficient and compliant trial execution. It also plays a growing role in supporting biologic as well as cell and gene therapy programs, with enhanced cold‑chain and cryogenic handling capabilities designed to meet the complex requirements of advanced therapies. As a critical hub within Catalent's global clinical supply network, the Philadelphia site helps sponsors accelerate development timelines while maintaining the highest standards of quality, flexibility, and regulatory compliance.

Our Philadelphia site is located in the Bensalem/Northeast Philadelphia area.

Position Summary

We have an opportunity for a Clinical Production Specialist to join our team. In this role, you will oversee the execution, training, and supervision of clinical production staff within a specific clinical packaging batch record operation. You will ensure safety, quality, production rates, material reconciliation, and adherence to timelines. This position requires knowledge of clinical applications such as randomization schedules, open label, blind labeling, study collation, and treatment groups. The work involves multiple packaging operations including blister cards, over-encapsulation, bottle filling, pouching, labeling, kit assembly, and distribution.

Shift: Monday - Friday, 7:45am to 4:10pm

Location: Philadelphia, PA

100% Onsite

The Role

• Monitor, organize, and perform all functions related to packaging of clinical trial supplies, ensuring compliance with Good Manufacturing Practices, Standard Operating Procedures, and regulatory requirements (FDA, DEA, OSHA) for assigned Production Batch Records
• Oversee assigned batch record operations in primary and secondary production rooms with various pharmaceutical packaging equipment such as automated bottle lines, form-fill-seal equipment, card sealing, vial and ampoule labelers, pouch equipment, and medical device tray sealing
• Ensure correct placement of multiple look-alike product combinations in blister units, cards, and bottles; Accurately enter data in batch records and logbooks
• Handle packaging of refrigerated and frozen clinical trial material
• Ensure security, accountability, and reconciliation of controlled substances in assigned clinical production operations
• Manage staging, reconciliation, and inventory label generation in the Enterprise Resource Planning system (JD Edwards)
• Track, monitor, and maintain production rates, labor hours, and downtime
• All other duties as assigned

The Candidate

Minimum Requirements

• High School Diploma or General Educational Development
• 1+ years of clinical, contract, or production experience
• Computer literacy, including Microsoft Word
• Working knowledge of current Good Manufacturing Practices, Drug Enforcement Administration, and Occupational Safety and Health Administration rules and regulations
• Knowledge of packaging equipment in a Just-in-Time environment

Preferred Skills & Background

• Associate's Degree or some college coursework preferred
• Experience in clinical trial manufacturing and packaging preferred
• Experience with JD Edwards or similar Enterprise Resource Planning systems

Why You Should Join Catalent

• Defined career path with annual performance reviews and feedback
• Diverse and inclusive culture
• Opportunities for career growth within a team dedicated to improving lives
• Competitive paid time off plus 8 paid holidays
• Community engagement and green initiatives
• Medical, dental, and vision benefits effective from day one
• 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.

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 DisabilityAccommodations@catalent.com. 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.

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