Manufacturing Lead Operator, Aseptic Process

Legend Biotech US • Raritan, NJ

5d • $83,711 - $109,870 • Onsite

About The Position

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

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.
• 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.

Nice To Haves

• Prior experience in an aseptic manufacturing environment is preferred.

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 decision 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.
• Supports 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.
• 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.
• Performs 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.
• Utilizes 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.
• Interacts with all levels within the organization through scientific and technical expertise.
• Builds strong partnerships with Manufacturing, Engineering, and Quality, and works as part of a cross-functional and matrixed team to successfully manufacture CAR-T product in a safe and high quality manner.

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Eight (8) weeks of paid parental leave after just three (3) months of employment
• Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
• Flexible spending and health savings accounts
• Life and AD&D insurance
• Short- and long-term disability coverage
• Legal assistance
• Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
• Voluntary commuter benefits
• Family planning and care resources
• Well-being initiatives
• Peer-to-peer recognition programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level