Clinical Production Specialist
About The Position
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
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
Nice To Haves
- 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
Responsibilities
- 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
Benefits
- Competitive paid time off plus 8 paid holidays
- Medical, dental, and vision benefits effective from day one
- Tuition reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
