Manufacturing Lead Operator, Aseptic Process

HireLifeScience; Raritan (NJ); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Restaurant on site

Job summary

Legend Biotech in Raritan, NJ is seeking a Manufacturing Lead Operator, Aseptic Process to join the Manufacturing & Operations team. You will work in a sterile, cGMP environment to produce CAR‑T products, applying engineering principles and rigorous process discipline on a shift basis.

The role requires a degree in engineering or a related field, hands-on experience with aseptic processing and ISO 5/ISO 7 cleanrooms, and strong data analysis to ensure product quality and compliance.

Qualifications

• Degree in engineering or related field required.
• Experience with CAR‑T manufacturing processes preferred.
• Working knowledge of GMP quality systems and regulatory requirements.

Responsibilities

• Establish time management and prioritization aligned with an engineering background.
• Support development of CAR‑T manufacturing processes with risk analyses.
• Drive continuous improvements and CAPA in cell therapy operations.
• Oversee production floor for BCMA CAR‑T Cell Therapy in ISO 5/ISO 7 environments.
• Apply lab science knowledge, cellular techniques and data analysis daily.
• Perform cell culture, purification, aseptic processing and cryopreservation per SOPs.

Skills

CAR-T manufacturing

Aseptic processing

GMP compliance

Data analysis

ISO 5/ISO 7

Education

Engineering or related field

Job description

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR‑T), T-cell receptor (TCR‑T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting‑edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta‑cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a Manufacturing Lead Operator, Aseptic Process as part of the Manufacturing & Operations team based in Raritan, NJ.

Role Overview

CAR‑T products and processes are a novel cell therapy, and thus are well supported by a degree in engineering or a related field where not only are valuable scientific and technical skills learned, but also the ability to connect ideas and analyze complex problems. This role will be part of the Technical Operations team responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team based on an assigned production shift schedule.

Key Responsibilities

• This individual establishes effective time management skills and prioritization of various job requirements, supported by a degree in engineering or related field to better analyze and execute effective decision during critical times for positive outcomes.
• To offer support in development of CAR‑T manufacturing processes, this individual requires an understanding of the underlying technical requirements of the process and product must have, where complex risk analyses and change management techniques are utilized to establish a high quality and safe drug product through periods of improvement.
• This individual with strong scientific and technical background, will support the development of manufacturing processes, and will work with technical support and engineering personnel to drive continuous improvements and implement corrective and preventative actions within cell therapy Technical Operations.
• This individual will be responsible for general production floor oversight of Legend Biotech's BCMA CAR‑T Cell Therapy Operations in both ISO 5 and ISO 7 environments, and support floor activities with extensive knowledge of CAR‑T cell therapy processes, GMP quality systems and their regulatory requirements.
• This individual requires prior in-depth knowledge of lab sciences, cellular lab techniques, and data analysis to complete daily responsibilities and assess the impacts and consequences in relation to other process areas, without jeopardizing quality, accuracy and efficiency.
• This individual will perform process unit operations (i.e. cell culture, purification, aseptic processing, and cryopreservation) performed within specialized BSL2+ ISO 5 and ISO 7 cleanroom environments, according to standard operating procedures and batch records, while recording production data and information in a