About Site

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses.

Position Summary

We have an opportunity for a CSS Team Lead - 3rd Shift to join our team supporting clinical trial projects through the packaging of clinical trial supplies. This role ensures all work is performed in compliance with regulatory requirements, good manufacturing practices, and standard operating procedures. The position oversees the process for the area, ensuring on-time startup and effective, compliant processing throughout the shift. The Team Lead provides staff support, training, and leadership to ensure successful execution of production batch records.

Shift: Sunday-Thursday 10:30pm-7am
Location: Kansas City, MO
100% Onsite

The Role

• Review packaging batch records before processing to ensure instructions follow standard operating procedures.
• Prepare and complete documentation in compliance with standard operating procedures and current good manufacturing practices.
• Review packaging batch records for completeness and accuracy, ensuring corrections are properly made.
• Inspect drug products, components, and clinical labels for defects or missing text before and during production.
• Perform Job Safety Analysis on new equipment.
• Analyze processes, recommend changes, and drive improvements.
• Use Entropy (safety system) and TrackWise (quality system) effectively.
• Conduct Gemba walks and use visual management boards and signage.
• Support the supervisor in daily activities and assist with safety and quality investigations using Root Cause Assessment and CAPA identification.
• Promote a “Patient First” mindset and maintain a respectful, professional workplace.
• Manage competing priorities and provide front-line leadership support when the supervisor is unavailable.
• Assist with action item completions, maintenance scheduling, and project kickoff meetings.
• Monitor Ready-to-Execute and coordinate on-time production start activities.
• Review equipment and room setups for compliance and productivity improvements.
• Capture daily information from Short Interval Control boards and complete required shift documentation.
• Perform other duties as assigned.

The Candidate

Minimum Requirements

• High School degree or equivalent required; bachelor’s degree in a science-related field preferred.
• Experience in clinical trial packaging or related packaging, manufacturing, or operations required.
• Ability to read, write, and speak English effectively.
• Strong written and verbal communication skills.
• Ability to interpret written, oral, diagram, or schedule instructions.
• Team-oriented with strong organizational skills aligned with 5S standards.
• Ability to work effectively under pressure while maintaining high quality standards.
• Moderate to advanced computer skills, including Microsoft Word, Microsoft Excel, Internet Explorer, Inventory Systems, and Quality Systems.
• Basic mathematical skills.
• Proven leadership and team management abilities.
• Ability to communicate and collaborate with external vendors when necessary.
• 20/30 corrected vision exam required.
• Respirator fit testing and pulmonary physical required.
• Handling of controlled substance product requires a DEA background check.
• Operation of a manual pallet jack required; may become licensed to operate the Pallet Stacker as needed.
• Must be available to work occasional overtime.

Preferred Skills & Background

• n/a

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• 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 [email protected]. 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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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