CAR-T Manufacturing Supervisor 2nd shift – Sunday to Tuesday, (Sunday to Wednesday bi-weekly)

6062-Janssen Pharmaceuticals Legal Entity•Raritan, NJ

21h•Onsite

About The Position

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. This role is part of a strategic collaboration between Janssen Biotech, Inc. (one of the Janssen Pharmaceutical Companies of Johnson & Johnson) and Legend Biotech USA Inc., focused on developing, manufacturing, and commercializing a chimeric antigen receptor (CAR) T-cell therapy. The position is located in Raritan, NJ.

Requirements

Minimum of an Associate's, Vocational, Technical/Trade, or equivalent degree/certificate is 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 6PM-6AM or 6PM-6:30AM 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

Nice To Haves

Bachelor's degree or focused degree in Science, Engineering, or related field 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

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

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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Consolidated retirement plan (pension)
Savings plan (401(k))