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 https://www.jnj.com
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.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for a CAR-T, Manufacturing Supervisor, 1st Shift - Sunday to Tuesday, (Sunday to Wednesday 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, 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)
Required to Work on Holidays if they fall on shift days
Shift is Sunday to Wednesday and then Sunday to Tuesday Bi-Weekly. Hours will be 7AM-630PM or 7AM-7PM and are subject to be adjusted in the event of business need.
Requires ability to lift up to 25 lbs and to stand for extended periods of time
May requireup to 10% domestic travel to other sites/locations
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
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 https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Agile Manufacturing, Analytics Dashboards, Chemistry, Manufacturing, and Control (CMC), Communication, Compliance Management, Data Compilation, Data Savvy, Developing Others, Gap Analysis, Good Manufacturing Practices (GMP), Inclusive Leadership, Leadership, Manufacturing Standards, Mentorship, Operational Excellence, Plant Operations, Process Optimization, Project Administration, Project Management, Technical Credibility
The anticipated base pay range for this position is :
$79,000 to $128,000
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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 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 Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
