Team Lead - 3rd Shift

Catalent Pharma Solutions; Kansas City (MO); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision benefits from

8 holidays PTO

Tuition reimbursement

Career growth opportunities

Job summary

Catalent Pharma Solutions in Kansas City, MO, seeks a CSS Team Lead for 3rd shift to supervise packaging of clinical trial supplies and ensure compliance with GMP and SOPs. The role emphasizes on-time startup, shift leadership, and staff training.

You will review batch records, inspect products, perform safety analyses, and drive process improvements using Entropy and TrackWise. Strong communication and 5S discipline are required, along with a DEA background check and PPE requirements.

Qualifications

• High School degree or equivalent; Bachelor's degree in a science-related field preferred.
• Experience in clinical trial packaging or related packaging, manufacturing, or operations.
• Ability to read, write, and speak English effectively.
• Strong written and verbal communication skills.
• Team-oriented with strong organizational skills aligned with 5S standards.
• Proficient with MS Word, Excel, Internet Explorer, inventory systems and quality systems.

Responsibilities

• 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.

Skills

Leadership

Team management

Communication

5S standards

English proficiency

Quality systems

Education

Bachelor's degree in a science-related field

High School diploma or equivalent

Tools

Entropy

TrackWise

Microsoft Word

Microsoft Excel

Inventory systems

Quality Systems

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.

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 [e-mail]. 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.

Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [e-mail] for us to investigate with local authorities.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability.

Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.

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.