Room Lead

Room 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 a Room Lead role. The Room Lead, supports clinical trial projects through the  packaging  of clinical  trial  supplies,  ensuring  work  is  carried  out  in  compliance  with  regulatory  requirements,  good manufacturing practices (cGMP) and standard operating procedures (SOPs). The Room Lead is key to ensuring the quality of outputs, adherence to the  production  schedule,  and  delegation  of  job-specific  tasks.  This position  oversees  the  execution  of  all clinical and commercial batch records in primary, secondary and the potent packaging areas. This position reports to the Production Supervisor but will also receive instruction from the Packaging Team Lead.

This is a full-time position: Hourly Role. Onsite. Monday – Sunday: Thursday: 10:30pm-7:00am

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 

• Ensure that during all packaging operations the site’s safety, quality and compliance metrics are met or surpassed as well as corporate metrics; Responsible for the safety, quality, delivery and cost (SQDC) of all clinical and commercial outputs
• Will lead assigned team members and work alongside them to successfully complete clinical trial and commercial packaging jobs on a daily basis
• Support supervisors in daily activities and assist production associated with QA questions and concerns
• Understand, interpret, and communicate organizational metrics and goals and lead assigned team members to consistently reach team and organizational goals
• Ensure that all employee batch records are reviewed, corrected, and submitted timely; Review of batch records with the room team prior to job start. Adhere to cGMP and GDP when completing and reviewing production batch records
• Alert management of any potential deviations or infractions in a timely manner
• Will implement and enforce 5S principles with guidance from Team Leads, Supervisors, and as required by company best practices
• Assess operator strengths and weaknesses and leverage this information when assigning tasks during batch execution and may be required to oversee multiple ongoing production operations and effectively delegate tasks to ensure the completion
• Must be able to clear a Drug Enforcement Agency (DEA) background check for handling controlled and special security drug substances and understands and enforces GMP gowning and de-gowning requirements for each production area (primary, secondary and potent packaging suites)
• All other duties as assigned;

The Candidate

• Required a High School Diploma or Equivalent
• A minimum of 2 years of clinical trial packaging experience or related manufacturing/operations experience preferred
• 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 empowe