Manufacturing Lead CAR T - 1st shift - Sunday-Tuesday, (Sunday-Wednesday 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 MedTech, 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. Learn more at jnj.com

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Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Pharmaceutical Process Operations

Job Category:

Business Enablement/Support

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 fora Manufacturing Lead CAR T 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!

Summary:

The Manufacturing Lead CAR-T is responsible for supporting in a leadership capacity in 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 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 (Supervisor Delegation)
• 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, operational procedures changes as an SME on the assigned process area, including manufacturing work instructions, master batch records, forms, and support and support change controls.
• 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. Manufacturing Leads should be qualified in the process they provide oversight to, to better understand Team challenges If a Manufacturing Lead for an Aseptic Process the Lead should maintain their APQ Qualifications and process in the event of staff shortages.
• In the event production runs past shift end time the Manufacturing Lead 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 3 years of relevant work experience in CAR-T Operations or equivalent 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, S4Hana, 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)

Preferred:

• Experienced in working in a lab as either as a Lab Technician, Operations Lead, Manufacturing Specialist or Manufacturing Operator
• Experience in an aseptic manufacturing environment (Clean Rooms & Laboratories)
• Operational Excellence and/or Lean Manufacturing experience, training, or certification

Other:

• This is a 1st Shift role (Sunday to Tuesday and then Sunday to Wednesday Bi-Weekly. Hours will be 6AM-6:00PM approximately and are subject to be adjusted in the event of business need.
• Required to Work on Holidays if they fall on shift days
• Requires ability to lift up to 25 lbs and to stand for extended periods of time
• May require up to 10% domestic travel to other sites/locations

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via , internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Agile Manufacturing, Analytical Reasoning, Analytics Dashboards, Business Behavior, Chemistry, Manufacturing, and Control (CMC), Communication, Data Analysis, Data Compilation, Data Savvy, Execution Focus, Gap Analysis, Good Manufacturing Practices (GMP), Manufacturing Standards, Operational Excellence, Plant Operations, Process Optimization, Project Administration, Technical Credibility

The anticipated base pay range for this position is :

$63,000.00 - $101,430.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: -