**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 Manufacturing Support Team Specialist. At the direction of the MST Manager, the Manufacturing Support Team specialist functions include investigations, training, continuous improvement, project management, technology transfer support, manufacturing document generation & revision, special projects and evaluating operations data analytics & metrics. The MST Specialist is responsible for adhering to policies and procedures with an emphasis on regulatory related processes such as SOPs, cGMP and safety in compliance with the CFRs and meets the business needs of the organization. The MST specialist will work in partnership with operations supervisors and Pharmaceutical Technicians **This is a full-time role position: Monday-Friday Days, 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** + Assist in writing SEPs/SIPs for equipment and instruments used by pharmaceutics and operations personnel. Evaluated reported issues to ensure they are addressed with appropriate degree of risk documentation. Evaluated issues against product history to identify root cause and trends + Lead and collaborate with other site functions to identify and implement improvements to processes and procedures that simplify and improve efficiencies while maintaining compliance with cGMPs and Catalent standards + Participate in defining “right” CAPA after investigation process is complete. Must be able to interact with employees at all levels inside and outside of the department as well as clients + Recommends changes and helps build training material to Operations Training Team, Pharmaceutical + Manufacturing Lead or Supervisor. Collaborates with Pharmaceutical Manufacturing Lead to ensure seamless communication is established and ongoing + Focuses on building proficiency with business critical equipment within core group while maintaining high quality standards. Ensures that areas of control are processing under GMP conditions and applicable SOP’s are being strictly followed + Drives reductions in unplanned deviations and focuses on troubleshooting identified equipment malfunctions with the Senior Pharmaceutical Technician, Pharmaceutical + Manufacturing Lead and Engineering/Maintenance. Participated with cross-functional teams to investigate potentially reportable events or those with potential business impact + Initiate, own, and manage manufacturing focused change controls, CAPAs, document creation and revisions, special projects and CI projects. Review documents with SME and Operations personnel to ensure they are accurate, executable and the formatting is consistent and harmonized + Ensures 5S standards are met and maintained. Ensure that the facility is kept “tour ready” at all times and people/material/flow/cleaning and zone concepts are maintained at all times. Ability to wear a PAPR (Powered Air Purifying Respirator) during manufacturing when required. Ability to wear required gowning required to work in the GMP manufacturing areas. Follows all Catalent safety procedures and identifies/communicates the necessary adjustments to address potential safety concerns. Will also ensure the proper use of PPE (Personal Protection Equipment) + All other duties as assigned; **The Candidate** + Required a High School Diploma with 7+ years of experience with Pharma or cGMP manufacturing environment; OR Technical degree/certification with 5+ years of experience with Pharma or cGMP manufacturing environment + Must have a thorough knowledge of cGMP, FDA, MHRA and DEA guidelines and how to apply them effectively + Thorough knowledge of Solid Dosage manufacturing preferred + Possess good communication and problem-solving skills highly desired + Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required + Individual may be required to sit, stand, walk regularly and occasionally lift up to 45 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) .