Manufacturing Lead Operator, Aseptic Process

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 clear, concise format.
• This individual will require critical thinking and troubleshooting skills to respond to patient specific product issues to ensure continuous flow of operations, while performing tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements within particular manufacturing processes.
• Establish key stakeholder relationships with internal and external stakeholders, as collaboration and understanding across functional stakeholders are essential to maintaining this dynamic, fast-paced environment, which is CAR-T manufacturing
• With a degree in engineering and related scientific or technical field, this individual must have the ability to interact with all levels within the organization through scientific and technical expertise
• Strong communicative skills and a broad technical understanding of complex systems are must haves, to build strong partnerships with Manufacturing, Engineering, and Quality, and work as part of a cross-functional and matrixed team to successful manufacture CAR-T product in a safe and high quality manner.

Requirements

• Bachelor’s degree in life science/engineering, or related field or equivalent experience required.
• A minimum of 2 years of operations experience within a cGMP environment in the biotech/biopharma industry. Prior experience in manufacturing, maintenance, quality, testing, or engineering is required. Prior experience in an aseptic manufacturing environment is preferred.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products.
• Ability to lift a minimum of 50 lbs and stand for a long period of time.
• Sufficient vision and hearing capability to work in job environment with physical dexterity sufficient to use computers and document production records.
• Ability to handle human derived materials in BSL-2 cleanroom facility.
• Physical dexterity sufficient to use computers and documentation.
• Ability to accommodate shift work including evenings and weekends as required by the manufacturing process.
• Ability to accommodate unplanned overtime on little to no prior notice.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals
  • Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses.
  • Color Perception both eyes 5 slides out of 8.
• AI Literacy: Possesses a working knowledge of AI technologies and approved AI tools, applies them responsibly to enhance productivity and decision-making, exercises appropriate human oversight of AI-generated outputs, and complies with organizational policies governing AI use.

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