**Pharmaceutical Manufacturing 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 Pharmaceutical Manufacturing Lead. The Pharmaceutical Manufacturing Lead at the direction of the Supervisor, is responsible for managing and providing direction for efficient set up / tear down, manufacture and cleaning of all equipment and processes associated with manufacturing operations. This position will have no direct reports. The Pharmaceutical Manufacturing Lead 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. **This is a full-time role position: Monday-Thursday -2nd shift. 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** + Responsible for gathering key performance metrics and reporting to Supervisor / department manager. Responsible for submitting work orders for processing rooms and equipment within core group. + Ensures 5S standards are met and maintained. Focuses on driving productivity improvements while maintaining high quality standards. Ensure that the facility is kept “tour ready” at all times and people/material/flow/cleaning and zone concepts are maintained at all times. + Creates training program for new technicians within core group. Updates and maintains training program as procedures evolve and continuous improvement ideas are implemented. Primary trainer for pharmaceutical technicians within core group. Will also evaluate associates training to identify any gaps or areas for improvement. + Ensures product is visually inspected to ensure quality requirements are thoroughly met. Supports multiple shift operations. Perform transactions in JDE accurately. Provides information to support core group metrics and efficiency increases. Supports customer requests as needed. + Drives reductions in unplanned deviations and focuses on troubleshooting identified equipment malfunctions. Pharmaceutical Manufacturing lead should have high ability to trouble shoot and repair, as well as manage the work order submission / follow-up process to ensure timely completion. Ensure communication / execution of quality system improvement ideas provided by team, and commit to maintaining effectiveness of quality system components relevant to process. Works with other Pharmaceutical Manufacturing leads, warehouse, and supply chain to ensure proper timing and coordinate smooth hand offs between core groups to ensure goals are being met. Supports and contributes to processing investigation/deviation analysis with GMP Support. + 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. Ensures that the Operators are adhering to all Catalent safety procedures and identifying/communicating the necessary adjustments to address potential safety concerns. Operating safely in a dynamic environment which includes mobile and fixed equipment and changing conditions while completing job tasks that range from simple to complex and/or multi-tasking. Must be capable of wearing steel-toed safety shoes for 8 to 12 hours a day, depending on duration of the shift. + Ensures proper documentation of all batch documents and review and approval of steps performed by other operators. (Pharmaceutical Manufacturing lead must be able to sign performed by & verified by steps). Provide feedback to scientists on batch record template issues to ensure clarity for processing. Ensures that areas of control are processing under GMP conditions and applicable SOP’s are being strictly followed + All other duties as assigned; **The Candidate** + Required a High School Diploma or Equivalent with a minimum of seven years of experience in Manufacturing and with five years of direct experience in a Pharma or cGMP manufacturing environment: OR Technical degree/certification with five years in a Pharma or cGMP manufacturing environment + Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required + Must have thorough equipment process and framework knowledge, SQDC leadership, process / process scheduling skill. Must have a thorough knowledge of cGMP, FDA, MHRA and DEA guidelines and how to apply them effectively. Thorough knowledge of Solid Dosage manufacturing. + 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 + 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) .