CAR-T Manufacturing Supervisor, 2nd Shift bi

Position: CAR-T Manufacturing Supervisor, 2nd Shift - Wednesday to Saturday, (Thursday to Saturday bi-weekly)
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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Job Function:
Supply Chain Manufacturing
Job Sub Function:
Manufacturing Pharmaceutical Process Operations
Job Category:
People Leader
All Job Posting Locations:
Raritan, New Jersey, United States of America
Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

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We are searching for the best talent for a CAR-T, Manufacturing Supervisor, 2nd shift - Wednesday to Saturday, (Thursday to Saturday bi-weekly) to join our Team in Raritan, NJ.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in the manufacturing of our pharmaceutical products? Apply today for this exciting opportunity!

The CAR-T Manufacturing Supervisor is responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Their job duties will be performed within a team-based environment, on an assigned production shift schedule.

Key Responsibilities:

• Lead and supervise a specific Processing Manufacturing Unit within the CART process operations (Day 0, Cell Culture, Day 10 or Component Prep)
• Lead daily shift operations meetings (Tier Meeting) where you would assign individuals their daily production task to complete and ensure compliance and successful completion of work-related tasks.
• Work closely with operations personnel on the production floor to provide clear guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Support manufacturing investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and handle change controls.
• Work with Operations Manager to help oversee the development of production personnel, provide input on personnel performance.
• Build positive relationships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for operators on the production floor.
• Support the development of manufacturing processes and work with cross-functional teams to drive continuous improvements and efficiencies within cell therapy Operations.
• Participate in various department projects and handle challenging priorities in a fast paced and dynamic environment
• Participate in production runs in critical situations when needed. Supervisors should be qualified in the process they provide oversight to, to better understand Team challenges
• In the event production runs past shift end time a supervisor will be required to stay with their processing unit until Batches are completed

Qualifications:

Education:

• Minimum of an Associate's, Vocational, Technical/Trade, or equivalent degree/certificate is required; Bachelor's degree or focused degree in Science, Engineering, or related field preferred

Experience and Skills:

Required:

• Minimum 2 years of relevant work experience Leading in Operations or Manufacturing within a cGMP environment (biotech/biopharma or engineering)
• Experience in Aseptic Manufacturing & Aseptic Techniques
• Excellent communication and interpersonal skills
• Advanced Experience in Microsoft Office tools (Word, Excel, PowerPoint, and Outlook, MS Channels, Teams, SharePoint)
• Advanced Computer Literacy and fully able to work in Electronic Systems such as Workday, SAP, Atlas, S4
  
  Hana, Elims, MES, Binocs, EMS, Scheduling Tools etc.
• Ability to Gown into Clean Room Attire to provide shop floor oversite of operations personnel (Scrubs, Safety Glasses, Hair Net, Face Mask, Clean Room Shoes, Grade B Suit)
• Required to Work on…