Principal Engineer, Lentivirus Downstream Process Development

Initial Therapeutics, Inc.; New Jersey; On-site; USD 146,000 - 192,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Job summary

Legend Biotech, based in Somerset, New Jersey, seeks a Principal Engineer for Lentivirus Downstream Process Development in the Technical Development team in Somerset, NJ. The role leads purification process design and optimization for LVV, including DSP steps like clarification, chromatography, and TFF to support GMP manufacturing and clinical programs.

The candidate will guide a team of scientists, transfer processes to manufacturing, author regulatory documents, and ensure robust, scalable,

Qualifications

• Advanced degree required; PhD preferred or MS with extensive biotech experience.
• 10+ years (MS) or 8+ years (PhD) in process development/manufacturing in biotech/pharma.

Responsibilities

• Design and optimize downstream purification strategies for lentiviral vectors for CAR-T applications.
• Lead development of DSP including clarification, chromatography, and TFF.
• Support GMP manufacturing transfer and tech transfer to/from Legend sites/CMOs.
• Review and author technical documents, regulatory submissions (CMC/IND/IMPD).
• Guide teams and ensure regulatory compliance and robust, scalable processes.

Skills

Leadership

Communication

Strategic thinking

Troubleshooting

Team leadership

GMP knowledge

Education

PhD preferred

MS degree

Tools

AEX chromatography

SEC chromatography

HIC chromatography

TFF

Sterile filtration

Job description

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.

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 leaderresponsible 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 optimizedfor 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 FlowFiltration (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.

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.

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