Senior Engineer / Principal Engineer, Vector Downstream

Role Overview

The Senior Engineer / Principal Engineer, Vector Downstream will be 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 for GMP manufacturing. The level and scope of responsibility will be determined based on the candidate's experience, technical expertise, and demonstrated impact.

Key Responsibilities

• Build state-of-the-art mechanistic and hybrid models that directly influence the development of LVV downstream processing, building operational efficiency through 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 modeling and clustering to generate process insights.
• Working closely with the team to implement development and optimization of downstream processes including clarification (depth filtration, centrifugation), chromatography (AEX, SEC, HIC), and Tangential Flow Filtration (TFF).
• Lead or support the translation of bench-scale processes to GMP manufacturing, ensuring seamless technology transfer and providing troubleshooting support during clinical production runs.
• Design/Implement different Advanced Process Control (APC) strategies (e.g., MPC, State Estimators) to optimize process performance.
• Communicate potential issues and delays along with solutions and mitigation approaches.
• In collaboration with senior leaders and cross-functional partners, identify project acceleration opportunities.
• Leverage advanced science and technology to maximize vector recovery, purity, and potency.
• Provide technical guidance and collaborate with scientists and cross-functional team members in the execution of project-specific activities.
• Author and serve as a primary reviewer for technical documents, including development reports, SOPs, and CMC sections for regulatory submissions.
• Work closely with Upstream Process Development and Analytical Development teams to ensure integrated process outcomes.
• Tech transfer process to/from other Legend sites or CDMOs.
• Proactively identify technical challenges and drive effective solutions and mitigation strategies.
• Ensure compliance with regulatory requirements.

Requirements

• Advanced degree (PhD preferred, or MS) in Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, or a related field.
• 6+ years (PhD) or 8+ years (MS) of experience in process development or manufacturing within a biotech or pharmaceutical setting. Candidates with additional experience and demonstrated technical leadership may be considered at the Principal Engineer level.
• Strong engineering knowledge of bioprocess modeling/simulation and the interaction of biomolecules, materials, and machinery.
• Experience with modeling software and programming languages such as Python and/or MATLAB preferred.
• Strong technical experience in purification, chromatography, and TFF, with demonstrated expertise in downstream process development.
• Understanding of GMP manufacturing requirements and CMC strategies for clinical-stage product development.
• Experience with lentiviral vector technologies preferred. Candidates with relevant viral vector, biologics, gene therapy, or advanced therapy process development experience will also be considered.
• Strong communication, collaboration, leadership, and problem-solving skills with the ability to influence cross-functional teams and navigate complex development timelines.
• Creative and 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 processes.
• Language(s): English. Mandarin is a plus.