Catalent, Inc.
pharmaceutical
ProductionLead
“Production Lead at Catalent, Inc.. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, packaging, clinical trial supplies, cGMP, SOPs. supports clinical trial projects through the packaging of clinical trial supplies by ensuring that all work is carried out in compliance with regulatory requirements, good manufacturing practices (cGMP) and standard operating procedures (SOPs). responsible for th”
What You'll Achieve.
ensuring on-time startup and effective and compliant processing through the shift
Industry & Context.
problem-solve using analytical skills; Root Cause Assessment techniques
Must be able to work overtime as required, able to perform duties which include standing, walking, sitting, kneeling, push/pulling frequently and significant amount of use of office, Must be able to lift up to 35lbs and work in temperature-controlled freezers/fridges frequently, Must be able to use a respirator, potential DEA background check screening may be required
What They're Looking For.
Must Have
minimum of six (6) years of relevant industry experience in a cGMP environment, clinical trial packaging, or related packaging/manufacturing operations environment, Must have at least four (4) years’ experience leading teams, Basic knowledge is required in Microsoft Office software and query-based systems activities as well as electronic batch record (EBR) software, Inventory Systems, Quality Systems, Supply Flex, Must be able to follow written and oral instructions in an accurate manner and problem-solve using analytical skills and/or Lean Six Sigma/5S methodology, Must be able to work overtime as required
Nice to Have
Bachelor’s degree highly preferred, High School Diploma/GED or equivalent required with 10+ years of relevant industry experience
What You'll Do.
supports clinical trial projects through the packaging of clinical trial supplies by ensuring that all work is carried out in compliance with regulatory requirements
good manufacturing practices (cGMP) and standard operating procedures (SOPs)
responsible for the overall process for the area
ensuring on-time startup and effective and compliant processing through the shift
ensures that all lines have the proper staff
and training to execute the production batch records
Review packaging batch records before
and after production to ensure accuracy
and adherence to SOPs and cGMP
including proper corrections and documentation
and maintain all required documentation and metric sheets in compliance with regulatory and internal standards
Inspect drug products
and clinical labels for defects
or missing text throughout production
Perform Job Safety Analysis (JSA) on new equipment and verify setup compliance against JSAs
Analyze operational processes
recommend improvements
and support continuous improvement activities
Perform Gemba walks and assist with completing action items
including corrections or CAPAs within TrackWise
Assist in Safety and Quality investigations using Root Cause Assessment techniques and support CAPA development and implementation
Attend project kickoff meetings and contribute effectively to planning and follow-through activities
Provide frontline leadership and decision-making for Packaging and Room operations
stepping in as acting supervisor when needed
Support supervisors with daily operational tasks
scheduling of planned maintenance
coordinating Ready‑to‑Execute status
and managing competing priorities while fostering a professional
patient‑focused workplace culture
How You'll Work.
Team & Collaboration
cross-functional coordination; Attend project kickoff meetings and contribute effectively to planning and follow-through activities; Provide frontline leadership and decision-making for Packaging and Room operations, stepping in as acting supervisor when needed; Support supervisors with daily operational tasks, scheduling of planned maintenance, coordinating Ready‑to‑Execute status, and managing competing priorities while fostering a professional, patient‑focused workplace culture
Process & Methodology
planning and follow-through activities
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