Manufacturing Lead Operator, Aseptic Process

About the role

Legend Biotech is seeking a Manufacturing Lead Operator, Aseptic Process as part of the Manufacturing & Operations team based in Raritan, NJ. 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 valuable scientific and technical skills are learned, along with 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.

Responsibilities

• 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 decisions during critical times for positive outcomes.
• Offers support in development of CAR-T manufacturing processes, requiring an understanding of the underlying technical requirements of the process and product, where complex risk analyses and change management techniques are utilized to establish a high quality and safe drug product through periods of improvement.
• With strong scientific and technical background, supports the development of manufacturing processes and works with technical support and engineering personnel to drive continuous improvements and implement corrective and preventative actions within cell therapy Technical Operations.
• 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 supports floor activities with extensive knowledge of CAR-T cell therapy processes, GMP quality systems and their regulatory requirements.
• Requires prior in-depth knowledge of lab sciences, cellular lab techniques, and data analysis to complete daily responsibilities and assess impacts and consequences in relation to other process areas, without jeopardizing quality, accuracy and efficiency.
• Performs process unit operations (i.e. cell culture, purification, aseptic processing, and cryopreservation) 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.
• Requires 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.
• Establishes 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, 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 successfully 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.
• 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.