Principal Engineer, Lentivirus Downstream Process Development

Legend Biotech USA; New Jersey; On-site; USD 180,000 - 240,000; Full time

Job summary

Legend Biotech USA seeks a Principal Engineer to lead lentivirus downstream process development within the Technical Development team in Somerset, NJ. You will design, optimize, and scale purification steps for LVV, focusing on CAR-T applications and GMP-ready DSP.

The role combines hands-on execution with strategic planning to accelerate timelines while maintaining patient-centered goals. The candidate will drive tech transfer, provide mentorship to scientists, and collaborate across upstream,

Qualifications

• Advanced degree in Chemical Engineering, Biomedical Engineering or related field.
• 8+ years (PhD) or 10+ years (MS) in process development or manufacturing in biotech/pharma.
• GMP requirements and CMC strategies for early-phase trials.
• Hands-on purification, chromatography, and TFF for viral vectors (Lentivirus preferred).
• Closed-system processing and cost optimization experience.
• Strong leadership and communication under tight timelines.
• Preferred experience in vector processes for in vivo CAR-T generation.
• Experience handling large-scale purification (>50 L).

Responsibilities

• Design and execute efficient purification strategies for LVV, optimized for CAR-T.
• Develop downstream processes: clarification, chromatography, and TFF.
• Provide hands-on training as needed.
• Translate bench-scale to GMP manufacturing and support tech transfer.
• Lead studies to define operating parameters and performance limits.
• Communicate issues and mitigation plans to stakeholders.
• Collaborate with senior leaders to identify acceleration opportunities.
• Maximize vector recovery, purity, and potency; drive innovation.
• Lead scientists, promote transparency and continuous improvement.
• Author and review development reports, SOPs, and CMC sections.
• Work with Upstream and Analytical Development for integrated outcomes.
• Execute tech transfer to/from Legend sites or CDMOs.
• Resolve conflicts and address performance issues.
• Ensure regulatory compliance.

Skills

Lentiviral DSP

GMP experience

Team leadership

Troubleshooting

Strategic thinking

Education

PhD preferred in Chemical/Biomedical/Bioprocessing engineering

MS degree in related field

Tools

AEX chromatography

SEC chromatography

HIC chromatography

TFF (Tangential Flow Filtration)

Job description

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 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.

Key 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 and not limited to: 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 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 principles of scaledown model 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 experiences 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.
• Strong troubleshooting skills.
• Preferred experience in developing vector processes tailored for in vivo CAR‑T generation and systemic delivery.
• Preferred experience in handling large scale(>50L) purification process.

#Li-JR1

#Li-Onsite

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Please note: These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. For information related to our privacy notice, please review: Legend Biotech Privacy Notice .