Manufacturing Lead CAR T - 1st shift – Sunday-Tuesday, (Sunday-Wednesday bi-weekly)

Johnson & Johnson•Raritan, NJ

5d•Onsite

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. The Manufacturing Lead provides leadership within a team-based production setting and is assigned to a production shift schedule. The role leads a specific processing unit within the CAR-T process, such as Day 0, Cell Culture, Day 10, or Component Prep. Leads are expected to be qualified in the process they oversee. For an aseptic process, the Lead is expected to maintain Aseptic Process Qualification (APQ) qualifications and process capability in the event of staffing shortages. If production continues beyond the scheduled shift, the Lead must remain with the processing unit until batches are completed. The position is a first-shift role, generally scheduled from 6:00 a.m. to 6:00 p.m. on Sunday through Tuesday, with a Sunday-through-Wednesday schedule every other week. Hours may be adjusted for business needs. The role requires holiday work when a holiday falls on a scheduled shift day. It may require up to 10% domestic travel to other sites or locations.

Requirements

At least 3 years of relevant experience in CAR-T operations or equivalent manufacturing within 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 such as Workday, SAP, Atlas, S4Hana, Elims, MES, Binocs, EMS, and scheduling tools.
Ability to gown in clean-room attire to provide production-floor oversight, including scrubs, safety glasses, hair net, face mask, clean-room shoes, and Grade B suit.
Ability to lift up to 25 pounds and stand for extended periods.
Ability to work holidays when they fall on scheduled shift days.
Ability to travel domestically up to 10% as required.
Minimum of an associate, vocational, technical/trade, or equivalent degree or certificate.

Nice To Haves

Bachelor's degree or a focused degree in science, engineering, or a related field.
Experience working in a laboratory as a Lab Technician, Operations Lead, Manufacturing Specialist, or Manufacturing Operator.
Experience in an aseptic manufacturing environment, including clean rooms and laboratories.
Operational Excellence and/or Lean Manufacturing experience, training, or certification.

Responsibilities

Lead a specific CAR-T processing manufacturing unit, such as Day 0, Cell Culture, Day 10, or Component Prep.
Lead daily shift operations (Tier) meetings, assign production tasks, and ensure work is completed successfully and in compliance.
Provide clear guidance to production-floor personnel and perform production tasks as needed, consistent with safety policies, quality systems, and cGMP requirements.
Support manufacturing investigations and operational procedure changes as a subject-matter expert for the assigned process area, including work instructions, master batch records, forms, and change controls.
Build effective 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 process development and collaborate with cross-functional teams to drive continuous improvement and operational efficiency in cell therapy operations.
Participate in department projects and manage challenging priorities in a fast-paced environment.
Participate in production runs during critical situations when needed.
Maintain qualifications for the process under oversight; for aseptic processes, maintain APQ qualifications and process capability as needed.
Remain with the processing unit if production runs beyond the scheduled shift, until batches are completed.

Benefits

Company consolidated retirement plan (pension) and 401(k) savings plan, subject to plan terms.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with different amounts 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 the birth, adoption, or foster care of a child.
Bereavement leave: 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.