Production Lead

Catalent • San Diego, CA

1d • $70,000 - $80,000 • Onsite

About The Position

The Production Lead 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). The Clinical Supply Services Production Lead is responsible for the overall process for the area, ensuring on-time startup and effective and compliant processing through the shift. The Production Lead ensures that all lines have the proper staff, support, and training to execute the production batch records.

Requirements

• Bachelor’s degree highly preferred with a minimum of six (6) years of relevant industry experience in a cGMP environment, clinical trial packaging, or related packaging/manufacturing operations environment
• High School Diploma/GED or equivalent required with 10+ years of relevant industry experience
• 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
• Able to perform duties which include standing, walking, sitting, kneeling, push/pulling frequently and significant amount of use of office equipment
• 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

Responsibilities

• Review packaging batch records before, during, and after production to ensure accuracy, completeness, and adherence to SOPs and cGMP, including proper corrections and documentation
• Prepare, complete, and maintain all required documentation and metric sheets in compliance with regulatory and internal standards
• Inspect drug products, components, and clinical labels for defects, blemishes, or missing text throughout production
• Perform Job Safety Analysis (JSA) on new equipment and verify setup compliance against JSAs, batch records, and SOPs.
• Analyze operational processes, recommend improvements, and support continuous improvement activities using tools such as visual management boards, entropy (safety system), and TrackWise (quality system)
• 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
• Other duties as assigned

Benefits

• Competitive salary with bonus potential
• Generous 401K match
• Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• 152 hours of PTO
• 10 paid holidays
• Tuition Reimbursement
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level