Production Lead

divh2Production Lead/h2pWork Schedule: Monday-Friday, core hours 8am-4:30pm 100% on-site (San Diego)/ppCatalent, 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 Catalents 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./ppThe 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./ppThe Role:/pulliReview packaging batch records before, during, and after production to ensure accuracy, completeness, and adherence to SOPs and cGMP, including proper corrections and documentation/liliPrepare, complete, and maintain all required documentation and metric sheets in compliance with regulatory and internal standards/liliInspect drug products, components, and clinical labels for defects, blemishes, or missing text throughout production/liliPerform Job Safety Analysis (JSA) on new equipment and verify setup compliance against JSAs, batch records, and SOPs./liliAnalyze operational processes, recommend improvements, and support continuous improvement activities using tools such as visual management boards, entropy (safety system), and TrackWise (quality system)/liliPerform 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/liliAttend project kickoff meetings and contribute effectively to planning and follow-through activities/liliProvide frontline leadership and decision-making for Packaging and Room operations, stepping in as acting supervisor when needed/liliSupport 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/liliOther duties as assigned/li/ulpThe Candidate:/ppBachelors 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./ppPay: 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./ppWhy you should join Catalent:/pulliAwesome 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./liliEnvironmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement./liliDefined career path and annual performance review and feedback process./liliPotential for career growth on an expanding team within an organization dedicated to preserving and bettering lives./liliSeveral Employee Resource Groups focusing on Diversity and Inclusion./liliCompetitive salary with bonus potential./liliGenerous 401K match and Paid Time Off accrual./liliMedical, dental and vision benefits effective day one of employment. 152 hours of PTO + 10 paid holidays./liliPositive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic./liliTuition Reimbursement Let us help you finish your degree or earn a new one!/liliWellHub program to promote overall physical wellness./liliPerkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories./liliCatalent 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./li/ulpCatalent 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./ppNotice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you./ppImportant Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond it is a fraudulent request. Please forward such requests to View email address on click.appcast.io for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE./ppCatalent, 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./p/div