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.

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, 3:45pm-12:15am (2nd Shift)
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
• Manage production involving manual and automated application of randomized labels on bottles, cards, cartons, kits, vials, syringes, and ampoules; Maintain and order personnel, safety, disposable, and support packaging supplies for assigned production room operations
• Ensure correct placement of multiple look-alike product combinations in blister units, cards, and bottles; Handle packaging of refrigerated and frozen clinical trial material
• Accurately enter data in batch records and logbooks; Review completed manufacturing and packaging batch records in a timely manner
• Ensure security, accountability, and reconciliation of controlled substances in assigned clinical production operations
• Manage staging, reconciliation, and inventory label generation in the ERP system (JD Edwards)
• All other duties as assigned

The Candidate

Minimum Requirements

• High School Diploma or GED; Associate Degree preferred
• 1+ years of clinical, contract, or production experience
• Must have computer proficiency to include the use of Microsoft Word
• Working knowledge of current Good Manufacturing Practices, DEA, and OSHA regulations
• Knowledge of packaging equipment in a Just-in-Time environment

Preferred Skills & Background

• Experience in clinical trial manufacturing and packaging
• Experience with JD Edwards or similar ERP systems

Why You Should Join Catalent

• Defined career path with annual performance reviews and feedback
• Diverse and inclusive culture
• Opportunities for career growth within an organization 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 program

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 someon