Principal Engineer, Lentivirus Downstream Process Development

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we develop advanced cell therapies across technology platforms including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. Our three R&D sites apply innovative technologies to discover safe, efficacious, and cutting-edge therapeutics for patients worldwide. Legend Biotech collaborates with Janssen to jointly develop and commercialize ciltacabtagene autoleucel (cilta-cel), combining expertise to advance immunotherapy for multiple myeloma.

About the role

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 downstream processing (DSP)—including clarification, chromatography, TFF, sterile filtration, and fill/finish—ensuring processes are robust, scalable, and phase-appropriate for GMP manufacturing. This position demands a blend of hands-on technical mastery and strategic thinking to accelerate timelines while maintaining a patient-focused approach.

Responsibilities

• Design and execute highly efficient purification strategies for lentiviral vectors, specifically optimized for CAR-T applications.
• Direct the development and optimization of downstream processes including clarification (depth filtration, centrifugation), chromatography (AEX, SEC, HIC), and Tangential Flow Filtration (TFF) for concentration and diafiltration.
• Provide hands-on training as needed.
• Direct the translation of bench-scale processes to GMP manufacturing, ensuring seamless technology transfer and providing troubleshooting support during clinical production runs.
• Lead the execution of study protocols to define operating parameters and performance limits; implement state-of-the-art knowledge management for DSP data.
• Communicate potential issues and delays along with solutions and mitigation approaches.
• In collaboration with 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.
• Facilitate tech transfer processes 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 principles of scale-down models and the interaction of biomolecules, materials, and machinery.
• Deep technical hands-on experience in purification, chromatography, and TFF specifically for viral vectors (Lentivirus preferred).
• Strong understanding of GMP manufacturing requirements and CMC strategies for early-phase clinical trials.
• Deep knowledge and hands-on experience in cell and lentiviral vector technologies within the current emerging field.
• Ability to implement closed-system processes and maximize cost-effectiveness.
• Excellent leadership, emotional intelligence, and communication skills; ability to maintain composure and strategic focus during challenging development timelines.
• Creative, strategic thinking with strong troubleshooting skills.

Preferred Qualifications

• Experience in developing vector processes tailored for in vivo CAR-T generation and systemic delivery.
• Experience in handling large-scale (>50L) purification processes.

Pay

Base pay range: $146,410 - $192,164 USD.

Other types of pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits

• Medical, dental, and vision insurance.
• 401(k) retirement plan with a company match that vests fully on day one.
• Eight weeks of paid parental leave after three months of employment.
• Paid time off policy including vacation time, personal time, sick time, floating holidays, and eleven company holidays.
• Flexible spending and health savings accounts.
• Life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.

Note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.