Packaging Team Lead

Manufacturing Support Team 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.

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.  The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions in Kansas City, MO is hiring a Manufacturing Support Team Specialist. The Kansas City (CDS) Clinical Development & Supply Team Lead supports clinical trial projects through the packaging of clinical trial  supplies;  ensuring  that  all  work  is  carried  out  in  compliance  with  regulatory  requirements,  good manufacturing practices (cGMP) and standard operating procedures (SOPs). The CSS Team Lead is responsible for the overall process for the area, ensuring on-time startup and effective and compliant processing through the shift. The Team Lead  ensures  that  all  lines  have  the  proper  staff,  support,  and  training  to  execute  the  production  batch  records.  This position reports to the Production Supervisor and may accept tasks from the Production Manager.

This is a full-time role position: Monday-Friday: 2:00pm-11:00pm -2nd 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  

• Accurately review packaging batch records prior to packaging process to ensure processing instructions are followed in accordance with SOPs. Prepare and complete documentation in compliance with SOPs and cGMP
• Review packaging batch records for completeness and appropriate documentation and ensure that any corrections to the packaging batch record are completed accurately
• Inspect drug products, components, and clinical labels for defects, blemishes or missing text prior to and during production
• Proficiently perform Job Safety Analysis (JSA) on new equipment. Ability to analyze processes, recommend changes and drive improvements
• Trained in the use of Entropy (safety system) and TrackWise (quality system). Perform Gemba walks. Use visual management boards and signage. Support supervisor in daily activities
• Assist with Safety and Quality investigations, utilizing Root Cause Assessment techniques, and CAPA identification. Must have a “Patient First” customer focus mindset. Will reinforce and support a respectful and professional workplace among all team members
• Must be able to successfully manage competing priorities and personalities.Provide front line leadership support and decision making to staff and act as supervisor for Packaging and Room operations when Supervisor is unavailable or needed
• Assist with action item completions (e.g., corrections in TrackWise)Assist with scheduling planned maintenance activities for equipment and facilities and any corresponding return to service. Attend project kickoff meetings and effectively contribute to the plan
• Monitor Ready-to-Execute and coordinate on-time start activities for production. Review equipment and room setups against JSAs, batch records, and SOPs – make changes accordingly to drive compliance and productivity
• Capture daily information from Short Interval Control boards and populate daily shift notes as well as other required metric sheets
• All other duties as assigned; 

The Candidate 

• Required a High School Diploma or Equivalent, bachelor’s degree in science-related field desired
• Five years of experienc