About the position
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 Product Lead. The Manufacturing Product Lead is responsible for providing technical support for oral solid dose (OSD) process manufacturing (tablets/capsules) including process improvements, tech transfer, process investigations, and process troubleshooting. Serves as a Subject Matter Expert (SME) for multiple processing operations and provides technical leadership for commercial product processes in collaboration with 1st shift Manufacturing Product Leads. 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.
Responsibilities
- Collaborates cross-functionally with Manufacturing, Engineering, Maintenance, EHS and Quality to optimize productivity, safety, product quality and supply reliability for commercial products in compliance with cGMPs
- Ensures commercial drug product manufacturing is Ready to Execute (RTE): Authors, reviews and approves commercial product manufacturing master batch records, BOMs, equipment recipes and cleaning verification forms as necessary to ensure RTE reliability
- Initiates process manufacturing area change proposals as required for assigned projects or in support of Manufacturing
- Partners with commercial clients as required on technical issues affecting their drug product(s). Acts as product technical steward on client interactions
- Provides technical support for process manufacturing areas, including investigation and correction of product/process-related problems and deviations, process troubleshooting and improvements
- Serves as a subject matter expert during internal audits and regulatory inspections for technical aspects of the drug product process
- Responsible for identifying, executing and implementing continuous improvement projects to reduce product cost, improve product quality, improve process safety and simplify processes to improve compliance
- Supports Manufacturing aspects of annual product reviews, continued process verification, product/process risk assessments, FMEAs, etc. Minimum of 25% shop floor/unit operation presence is required to successfully support manufacturing
- Leads technology transfer and implementation of new technologies, equipment, and processes from R&D and other sites, into the Kansas City facility or out to other Catalent sites, as well as between clinical and commercial manufacturing
- All other duties as assigned
Requirements
- Bachelor of Science degree required; preferably in engineering, science or other related technical discipline. A minimum of 15 years of pharmaceutical manufacturing experience may be substituted for the degree requirement
- Minimum requirement of one year of experience with Oral Solid Dosage (OSD) manufacturing or pharmaceutical operations. Experience in pharmaceutical production and process engineering preferred
- Must have familiarity with Microsoft Office (Word, Excel, Outlook, Teams, etc.), and experience with Minitab and/or SharePoint is preferred
- Must have client facing customer service experience
- Understanding of cGMPs, demonstrated leadership, management and technical capabilities preferred
- Experience with equipment IQ/OQ/PQ preferred
- Experience in Lean Manufacturing/OpEx and Six Sigma is desired
- Individual may be required to sit, stand, walk regularly and occasionally lift up to 25 pounds
- Occasional requirement to work in cold environment (walk-in refrigerator/freezer)
Benefits
- 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
