**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 experience in Clinical trial packaging or related packaging/ manufacturing/ operations experience required + Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience + Required Leadership skills include excellent interpersonal and communication skills with all levels of stakeholders, the strong ability to lead, mentor, train, motivate, direct and empower a team, influence and lead change, contribute strategic, analytical insight for problem solving and partner with cross functional teams to identify gaps, develop and implementation of continuous improvement ideas + Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required + Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds + 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 of PTO + 8 paid holidays + Several Employee Resource Groups focusing on D&I + Dynamic, fast-paced work environment + Community engagement and green initiatives + Generous 401K match + 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) .