Production Lead

About the role

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 The Candidate: 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 We will accept a High School Diploma/GED or equivalent required with 10+ years of relevant industry experience (defined above) 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 Physical requirements: 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, and potential DEA background check screening may be required Pay: The anticipated salary range for this role in San Diego, CA is $70,000 to $80,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states. Why you should join Catalent: Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment. Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Cle

Additional Information

Production Lead Position Summary: Work Schedule: Monday-Friday, core hours 8am-4:30pm 100% on-site (San Diego) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and clinical returns and destruction, and will also include stability chambers. Located less than a mile from Catalent's West Coast early-phase oral drug product development center of excellence, customers choosing this convenient Catalent location can now enjoy a fully integrated development, clinical supply manufacturing and distribution solution. 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.

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