Production Lead

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 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. 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. 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 requiredli> 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 35 lbs 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 encourage positive employee camaraderie, overall creating a positive work environment. Environmentally friendly green initiatives with on‑site practices as well as regularly participating in Beach Clean‑up activities for community engagement. Defined career path and annual performance review and feedback Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives. Several Employee Resource Groups focusing on Diversity and Inclusion. Competitive salary with bonus potential. Generous 401(k) match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment. 152 hours of PTO + 10 paid holidays. Positive and fast‑paced working environment focusing on continually improving processes to remain innovative and dynamic. Tuition Reimbursement – Let us help you finish your degree or earn a new one! WellHub program to promote overall physical wellness. Perkspot – offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories. Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to View email address on click.appcast.io. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. #J-18808-Ljbffr Catalent Pharma Solutions