Principal Engineer, Lentivirus Downstream Process Development

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.

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The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

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

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include 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. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$146,410-$192,164 USD

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