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Legend Biotech

Develops and commercializes cell therapies

Senior Engineer / Principal Engineer - Vector Downstream

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeSomerset County, NJ, USA

About the Job

Requirements

  • An advanced degree (PhD preferred, or MS) in Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, or a related field is required.
  • At least 6 years of process development or manufacturing experience in a biotech or pharmaceutical setting with a PhD, or at least 8 years with an MS; additional experience and demonstrated technical leadership may qualify candidates for the Principal Engineer level.
  • Strong engineering knowledge of bioprocess modeling and simulation and the interactions of biomolecules, materials, and machinery.
  • Experience with modeling software and programming languages such as Python and/or MATLAB is preferred.
  • Strong technical experience in purification, chromatography, and tangential flow filtration, with demonstrated expertise in downstream process development.
  • Understanding of good manufacturing practice (GMP) requirements and chemistry, manufacturing, and controls (CMC) strategies for clinical-stage product development.
  • Experience with lentiviral vector technologies is preferred; relevant viral vector, biologics, gene therapy, or advanced therapy process development experience is also considered.
  • Strong communication, collaboration, leadership, and problem-solving skills, including the ability to influence cross-functional teams and navigate complex development timelines.
  • Creative and strategic thinking.
  • Strong troubleshooting skills.
  • English language proficiency is specified; Mandarin is a plus.

Responsibilities

  • Build mechanistic and hybrid models to guide lentiviral vector downstream processing and improve operational efficiency using model-first and artificial intelligence-enabled development strategies.
  • Apply mass transfer, fluid mechanics, and thermodynamics to build robust in silico process models.
  • Use machine-learning algorithms for modeling and clustering to generate process insights.
  • Work with the team to implement and optimize downstream processes, including clarification by depth filtration and centrifugation, chromatography using anion exchange chromatography, size-exclusion chromatography, and hydrophobic interaction chromatography, and tangential flow filtration.
  • Lead or support translation of bench-scale processes to GMP manufacturing, ensuring technology transfer and troubleshooting during clinical production runs.
  • Design and implement advanced process control strategies, such as model predictive control and state estimators, to optimize process performance.
  • Communicate potential issues and delays and propose solutions and mitigation approaches.
  • Identify project-acceleration opportunities with senior leaders and cross-functional partners.
  • Use advanced science and technology to maximize vector recovery, purity, and potency.
  • Provide technical guidance and collaborate with scientists and cross-functional team members on project-specific activities.
  • Author and serve as a primary reviewer for technical documents, including development reports, standard operating procedures, and CMC sections for regulatory submissions.
  • Work with upstream process development and analytical development teams to ensure integrated process outcomes.
  • Transfer processes to and from other Legend sites or contract development and manufacturing organizations.
  • Identify technical challenges and drive effective solutions and mitigation strategies.
  • Ensure compliance with regulatory requirements.

Desired Qualifications

  • Experience developing vector processes tailored for in vivo CAR-T generation and systemic delivery.
  • Experience with large-scale purification processes greater than 50 liters.

About the Company

Legend Biotech

Develops and commercializes cell therapies

Legend Biotech develops and commercializes cell therapies for serious diseases, especially hematological cancers and solid tumors, using multiple technology platforms. Its CAR-T therapies modify a patient’s own T cells to fight cancer, and the company licenses and sells these therapies while pursuing additional research. By pursuing a technology-agnostic pipeline, Legend Biotech aims to bring effective, personalized treatments to patients globally. The company also maintains investor communications to share progress and results.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Bridgewater Township, New Jersey
Founded
2014

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