Team Lead - 3rd Shift

Catalent; Kansas City (MO); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Paid time off

8 paid holidays

Medical, dental, and vision benefits

Tuition reimbursement

Job summary

Catalent’s Kansas City facility leads in clinical supply services and packaging for late-stage programs. We seek a CSS Team Lead on 3rd shift to supervise packaging of clinical trial supplies, ensure GMP compliance, and provide staff training and leadership.

The role requires reviewing batch records, coordinating start-up, and driving process improvements across the shift. Onsite, Sunday-Thursday 10:30pm–7am, you will collaborate with QA, safety, and operations to maintain patient-first quality.

Qualifications

• High School degree or equivalent; bachelor’s degree in a science field preferred.
• Experience in clinical trial packaging or related packaging/manufacturing/operations.
• Ability to read, write, and speak English effectively.
• Strong written and verbal communication skills.
• Team-oriented with 5S standards.
• Ability to work under pressure while maintaining high quality standards.
• Moderate to advanced computer skills including Word, Excel, Internet Explorer, Inventory Systems, and Quality Systems.
• DEA background check required for handling controlled substances.
• Operation of a manual pallet jack; may become licensed for Pallet Stacker.
• Available for occasional overtime.

Responsibilities

• Review packaging batch records for SOP compliance.
• Prepare and document in GMP/SOPs.
• Review batch records for completeness and accuracy.
• Inspect drug products, components, and labels for defects.
• Perform Job Safety Analysis on new equipment.
• Analyze processes and drive improvements.
• Use Entropy and TrackWise effectively.
• Conduct Gemba walks and use visual boards.
• Support supervisor with safety and quality investigations.
• Promote a Patient First mindset and maintain a professional workplace.
• Provide frontline leadership when 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 shift documentation.
• Perform other duties as assigned.

Skills

Leadership

Team management

Communication skills

5S standards

Education

Bachelor's degree in a science field

Tools

TrackWise

Entropy

Job description

About Site

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

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.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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