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:We are searching for the best talent for a CAR-T, Manufacturing Supervisor,
1st shift - Wednesday-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, 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 Wednesday-Saturday and then Thursday to Saturday Bi-Weekly. Hours will be 6AM-6PM or 6AM-6:30PM 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 require up 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
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 :$79,000.00 - $127,650.00
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: - https://www.careers.jnj.com/employee-benefits
