**Team Lead** **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 Team Lead. 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, on-site hourly position: Monday – Friday, 6:30am-3:00pm.** **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 product, 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 + Assist with scheduling planned maintenance activities for equipment and facilities and any corresponding return to service + All other duties as assigned **The Candidate:** + High School Diploma or General Education Diploma is required + Bachelor’s Degree in Science related field is preferred + At least one year of Clinical Trial Packaging or related Packaging/Manufacturing/Operations experience is required + Working computer knowledge of Microsoft Outlook, Word, Excel, Internet Explorer is required + **Physical Requirements:** On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently. Occasional requirement to work in cold environment to fill orders (walk-in refrigerator/freezer) **Why you should join Catalent:** + Defined career path and annual performance review and feedback process + Diverse, inclusive culture + Positive working environment focusing on continually improving processes to remain innovative + Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives + 152 Hours + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + Company match on donations to organizations + Medical, dental and vision benefits effective day one of employment + Tuition Reimbursement – Let us help you finish your degree or start a new degree! + WellHub program to promote overall physical wellness + Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories **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 (https://careers.catalent.com/us/en) 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 DisabilityAccommodations@catalent.com . 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 spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .