Senior Engineer / Principal Engineer, Lentivirus Downstream Process Development

legendcareers; New Jersey; On-site; USD 140,000 - 190,000; Full time

Job summary

Legend Biotech seeks a Senior/Principal Engineer for Lentivirus Downstream Process Development in Somerset, NJ. This role designs, optimizes, and scales purification steps for LVV, ensuring robust GMP manufacturing readiness and technology transfer across sites.

The candidate will build mechanistic and hybrid models, apply ML for process insights, and collaborate with Upstream and Analytical Development to maximize vector recovery, purity, and potency.

Qualifications

• Advanced degree in Chemical/Biochemical/Bioprocess Engineering.
• 6+ years (PhD) or 8+ years (MS) in biotech process development or manufacturing.
• Experience with bioprocess modeling/simulation.
• Experience with Python and/or MATLAB.
• Strong expertise in downstream purification, including chromatography and TFF.
• Understanding GMP requirements for clinical‑stage product development.

Responsibilities

• Design, optimize, and scale LVV downstream purification processes for GMP manufacturing.
• Build mechanistic and data-driven models to guide development and tech transfer.
• Apply ML/analytics to generate process insights and drive optimization.
• Coordinate with upstream, analytics, and cross‑functional teams for integrated outcomes.
• Lead or support technology transfer to GMP facilities and CDMOs.
• Develop APC strategies (e.g., MPC, state estimators) to enhance performance.
• Identify risks and mitigation plans; ensure regulatory readiness.

Skills

Bioprocess modeling

GMP knowledge

Process scale-up

Downstream purification

Chromatography

APC control strategies

Education

PhD in Chemical/Biochemical/Bioprocess Engineering

MS in Chemical/Biochemical/Bioprocess Engineering

Tools

Python

MATLAB

Job description

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life‑threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T‑cell (CAR‑T), T‑cell receptor (TCR‑T), natural killer (NK) cell‑based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting‑edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta‑cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

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

Role Overview

The Senior Engineer / Principal Engineer, Lentivirus Downstream Process Development 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 exp