Pharmaceutical Manufacturing Lead

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, onsite position: Monday-Thursday -2nd shift. 

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
• Creates training program for new technicians within core group; updates and maintains training program as procedures evolve and continuous improvement ideas are implemented
• Ensures product is visually inspected to ensure quality requirements are thoroughly met; supports multiple shift operations
• Drives reductions in unplanned deviations and focuses on troubleshooting identified equipment malfunctions
• 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 proper documentation of all batch documents and review and approval of steps performed by other operators; provide feedback to scientists on batch record template issues to ensure clarity for processing
• All other duties as assigned

The Candidate 

• High School Diploma or Equivalent with a minimum of seven years of experience in Manufacturing and 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 is required
• 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