Downstream Process Development Jobs in New Jersey

Legend Biotech is seeking a Principal Engineer, Lentivirus Downstream Process Development as part of the Technical Development team based in Somerset, NJ.

Role Overview

The Principal Engineer, Lentivirus Downstream Process Development, will be a key technical leader responsible for designing, optimizing, and scaling purification processes for lentiviral vectors (LVV) within our
innovative pipeline. This role focuses on delivering high-quality vector products to support LVV generation and other advanced cell therapy programs. The successful candidate will drive scientific excellence in scaling automation capabilities from concept to operation, integrating analytics, and modeling into downstream workflows, and translating microscale insights into robust, scalable processes-ensuring processes are robust, scalable, and phase-appropriate for GMP manufacturing.

Key Responsibilities

• Build state-of-the-art mechanistic and hybrid models that directly influence the development of LVV downstream processing, build operational efficiency by model-first and AI-enabled development strategies.
• Apply core engineering concepts including mass transfer, fluid mechanics, and thermodynamics to build robust in silico process models.
• Perform data analytics using ML algorithms for modelling and clustering to generate process insights.
• Working closely with team to implement development and optimization of downstream processes including and not limited to: clarification (depth filtration, centrifugation), chromatography (AEX, SEC, HIC), and Tangential Flow Filtration (TFF) for concentration and diafiltration.
• Direct the translation of bench-scale processes to GMP manufacturing by simulation plus wet lab, ensuring seamless technology transfer and providing troubleshooting support during clinical production runs.
• Design/ Implement different Advanced Process Control (APC) strategy (e.g., MPC, State Estimators) to optimise process performance.
• Communicate the potential for issues and delays along with solutions and mitigation approaches.
• In collaboration with the Senior Leaders, CMC Project Manager, Project Leader, and other technical leads identify project acceleration opportunities.
• Leverage advanced science and technology to maximize vector recovery, purity, and potency, identifying creative solutions to define unknowns in the viral vector field.
• Guide a team of scientists in the execution of project-specific activities, fostering a culture of transparency, scientific rigor, and continuous improvement.
• Author and serve as a primary reviewer for technical documents, including development reports, SOPs, and CMC sections for regulatory submissions (IND/IMPD).
• Work closely with Upstream Process Development and Analytical Development teams to ensure integrated and holistic process outcomes.
• Tech transfer process to/from other Legend sites or CDMOs
• Resolve conflict and proactively identify/address performance issues.
• Ensure compliance with regulatory requirements.

Requirements

• Advanced degree (PhD preferred, or MS) in Chemical Engineering, Biomedical Engineering, bioprocessing engineering or a related field.
• 8+ years (PhD) or 10+ years (MS) of experience in process development or manufacturing within a biotech or pharmaceutical setting.
• Strong engineering knowledge of the bioprocessing modeling/simulation and the interaction of biomolecules, materials and machinery.
• Experience with modeling software and programming language such as Python and MATLAB.
• Deep technical experience in purification, chromatography, and TFF. 
• Strong understanding of GMP manufacturing requirements and CMC strategies for early-phase and late phase clinical trials. 
• Deep knowledge in lentiviral vector technologies within the current emerging field
• Excellent leadership, emotional intelligence, and communication skills; ability to maintain composure and strategic focus during challenging development timelines.
• Creative, strategic thinking
• Strong troubleshooting skills
• Preferred experience in developing vector processes tailored for in vivo CAR-T generation and systemic delivery
• Preferred experience in large scale(>50L) purification process
• Language(s): English. Mandarin is a plus

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