Manufacturing Lead CAR T - 1st shift – Sunday-Tuesday, (Sunday-Wednesday bi-weekly)
About The Position
Johnson & Johnson is seeking a Manufacturing Lead CAR T to join its team in Raritan, New Jersey. The role supports daily production of personalized cell therapy for clinical and commercial requirements in a sterile cGMP environment, working in a team-based setting on an assigned production shift schedule. The position is part of a strategic collaboration between Janssen Biotech, Inc. and Legend Biotech USA Inc. to develop, manufacture, and commercialize CAR T-cell therapy. The Manufacturing Lead provides leadership for a designated processing unit and supports production operations, team task assignment, compliance, and completion of work. The role collaborates with Manufacturing, Engineering, and Quality, contributes to investigations and procedural changes, and supports process development and continuous improvement. The Lead may perform production work in critical situations and must remain with the processing unit when production runs beyond the scheduled shift end. This is a first-shift role, generally scheduled Sunday through Tuesday and, on a biweekly basis, Sunday through Wednesday, approximately 6:00 a.m. to 6:00 p.m. Hours may be adjusted based on business needs. Holiday work is required when holidays fall on scheduled shift days. The role may require up to 10% domestic travel and involves cleanroom attire, lifting up to 25 pounds, and standing for extended periods.
Requirements
- At least an Associate's, vocational, technical/trade, or equivalent degree or certificate.
- At least 3 years of relevant experience in CAR-T operations or equivalent manufacturing in a cGMP environment, such as biotech, biopharma, or engineering.
- Experience in aseptic manufacturing and aseptic techniques.
- Excellent communication and interpersonal skills.
- Advanced experience with Microsoft Office tools, including Word, Excel, PowerPoint, Outlook, MS Channels, Teams, and SharePoint.
- Advanced computer literacy and ability to work with electronic systems, including Workday, SAP, Atlas, S4Hana, Elims, MES, Binocs, EMS, and scheduling tools.
- Ability to gown in cleanroom attire, including scrubs, safety glasses, hair net, face mask, cleanroom shoes, and Grade B suit.
- Ability to work holidays when they fall on scheduled shift days.
- Ability to lift up to 25 pounds and stand for extended periods.
- Availability for up to 10% domestic travel to other sites or locations.
Nice To Haves
- Bachelor's degree, preferably in Science, Engineering, or a related field.
- Experience in a laboratory as a Lab Technician, Operations Lead, Manufacturing Specialist, or Manufacturing Operator.
- Experience in aseptic manufacturing environments, including cleanrooms and laboratories.
- Operational Excellence and/or Lean Manufacturing experience, training, or certification.
Responsibilities
- Lead a specific processing manufacturing unit within CAR T process operations: Day 0, Cell Culture, Day 10, or Component Prep.
- Lead daily shift operations (Tier) meetings, assign daily production tasks, and ensure work is completed compliantly and successfully.
- Guide operations personnel on the production floor and perform production tasks as needed while following safety policies, quality systems, and cGMP requirements.
- Support manufacturing investigations and operational procedure changes as a subject matter expert in the assigned process area, including work instructions, master batch records, and forms; support change controls.
- Build positive working relationships with Manufacturing, Engineering, and Quality to support daily production and address production issues as the first point of contact for operators on the production floor.
- Support manufacturing process development and collaborate with cross-functional teams on continuous improvements and efficiencies in cell therapy operations.
- Participate in department projects and manage challenging priorities in a fast-paced environment.
- Participate in production runs in critical situations and maintain qualification in the process area being overseen; for aseptic processes, maintain APQ qualifications and process capability in the event of staff shortages.
- Remain with the processing unit when production extends beyond the scheduled shift end until batches are completed.
Benefits
- Retirement plan (pension) and savings plan (401(k)), subject to plan terms.
- Vacation: 120 hours per calendar year, subject to policy and hire date.
- Sick time: 40 hours per calendar year, with specified higher allotments for employees residing in Colorado or Washington.
- 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 a child's birth, adoption, or foster care placement.
- Bereavement leave: up to 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
- Caregiver leave: 80 hours in a 52-week rolling period.
- Volunteer leave: 32 hours per calendar year.
- Military spouse time-off: 80 hours per calendar year.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
