Clinical Production Specialist

Clinical Production Specialist 

Position Summary

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.

This 206,878 square-foot facility, located in the Philadelphia area is Catalent’s global Center of Excellence for Clinical Supply Packaging.  Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs.  Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.

Catalent Pharma Solutions in Philadelphia is hiring a Clinical Production Specialist. Assigned to and responsible for the overall execution, training, monitoring and supervising clinical production staff within a specific clinical packaging batch record operation.  Responsible for safety, quality, production rates, material reconciliation, BRNRFT, and timelines adherence in the specific production batch record operation assigned to. This position requires a general knowledge of clinical applications regarding randomization schedules, open label, blind labeling, study collation and treatment groups. Department assignments cover multiple look-alike blister card packaging, over-encapsulation, bottle filling, pouching operations, clinical labeling, kit assembly, collating and distribution

This is a full-time role position: Monday-Friday: 7:45am - 4:15pm. 1st shift. Hourly, Onsite

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role  

• Monitors, organizes and performs all functions associated with packaging of clinical trial supplies and assures compliance to GMPs, SOPs, FDA, DEA and OSHA rules and regulations in the specific production batch record assigned to
• Oversees specific batch record operations assigned to which includes both primary and secondary production rooms equipped with various pharmaceutical packaging equipment including but not limited to: automated bottle line, form, fill and seal equipment, card sealing, vial and ampoule labelers, pouch equipment and medical device tray sealing
• Responsible for production involving manual and automated application of randomized labels on bottles, cards, cartons, kits, vials, syringes and ampoules
• Responsible for insuring correct placement of multiple look-alike product combinations in blister units, cards and bottles
• Responsible for maintaining and ordering personnel, safety, disposable and support packaging supplies for specific assigned production room operation
• Responsible for entering data accurately in batch records and logbooks
• Must review completed manufacturing and packaging batch records in a timely manner
• All other duties as assigned; 

The Candidate 

• Required a High School Diploma or Equivalent.
• Associates Degree Highly preferred
• One+ years Clinical, contract or production experience preferred
• Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required
•  JD Edwards experience or similar ERP systems highly desired
•  Working knowledge of cGMPs,