CAR-T Process Engineer

Company Information

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Role Overview

The CAR-T Process Engineer will be part of the MS&T team and will be responsible to:

• Participate to the design and implementation of Process Validation / Engineering activities to support the Strategic Plan
• Provide scientific knowledge and cGMP expertise in cell and gene therapy processes and/or process technologies to establish the appropriate holistic Process Control Strategy.
• Support and ensure cGMP readiness of the product process through an appropriate validation strategy in compliance with regulations, procedures and the validation master plan
• Provide ad hoc scientific support to the Investigation team and bring knowledge in order to allow resolution of deviations and atypical events.
  
  

Major Responsibilities:

The CAR-T Process Engineer reports to the Process Validation/Engineering Lead and is responsible for:

• Process Robustness (Engineering/Validation)
• Participate to the design and implementation of Process Validation / Engineering activities to support the Strategic Plan
• Provide support, scientific and technical expertise in the Technical Operations group, own the process knowledge of the cell and gene therapy manufacturing process technology to support tech transfer/validation activities into and out of the Ghent facilities.
• Draft and maintain Manufacturing Batch records and related documentation up to date.
• Participate to the establishment and maintenance the Master Validation Plan related to the manufacturing process.
• Design studies necessary to successfully implement/validate the manufacturing process: Draft/review documentation (protocols and reports, flow diagrams, instructions, training) and oversee execution.
• Build knowledge/expertise within the team to define robust Process and Contamination Control strategies, including sterility assurance.
• Draft Process Risk Assessments for the implementation of process changes.

• Quality & Compliance
• Support and ensure cGMP readiness of the product process through appropriate transfer/validation plan.
• Serve as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
• Provide ad hoc technical/scientific assessment, recommendations and support to cGMP documentation: Change Controls, deviations and CAPAs
• Provide scientific expertise to help identify true root cause of investigations and assess product quality impact.
• Assure regulatory compliance and technical feasibility of proposed changes.
• Review and approve SOP and Batch record

• Continuous Improvement / Operational Excellence
• Identify opportunities for process improvements related to safety, environmental, quality, compliance, productivity, yield, and cost, and drive implementation aligned with the change control strategy.
• Partner with all relevant teams and/or external vendors to implement process improvements. Work with vendors to evaluate new raw materials and consumables for compatibility with the Manufacturing process.
• Contribute to data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the Statistical Quality Control Database (SQC) and the Annual Product Review (APR).
• Technology watch: Keep up to date on the most recent CAR-T product & process updates (develop network of service providers & suppliers, participate to congresses…) and liaise with other technical development teams.
  

Qualification

Education:

A minimum of a Master degree in Engineering, Science, Pharmacy or related field or equivalent experience required.

Experience:

Minimum 3 years of operations experience within a cGMP (Manufacturing/Quality or Development) environment in the biotech/biopharma industry.

Cell And Gene Therapy Manufacturing Experience Preferred.

Capabilities, Knowledge, and skills:

• Ability to work cross-functionally and successfully.
• High organizational skills: prioritize and manage multiple tasks simultaneously. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Good communication skills (both written and oral)
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Self-motivated, enthusiastic and empathetic
• Ability to work precisely, according to procedures and rules
• Result driven
• Understanding of statistical analysis using software like jmp.
  

Languages

Dutch and English (at least fluent)

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.