Principal Engineer, Lentivirus Downstream Process Development

Legend Biotech US; New Jersey; On-site; USD 146,410 - 192,164; Full time

Job summary

Legend Biotech USA in Somerset, NJ, is seeking a Principal Engineer for Lentivirus Downstream Process Development within the Technical Development team. You will design, optimize, and scale purification processes for lentiviral vectors, enabling LVV generation for advanced cell therapies, with a strong emphasis on GMP readiness and tech transfer.

The role requires advanced degrees with 8+ years (PhD) or 10+ years (MS) of related experience, and hands-on expertise in purification, chromatography,

Qualifications

• Advanced degree in Chemical/Biomedical Engineering or related field.
• 8+ years (PhD) or 10+ years (MS) in biotech process development/manufacturing.

Responsibilities

• Design and optimize purification strategies for lentiviral vectors for CAR-T applications.
• Develop downstream processes including clarification, chromatography, and TFF.
• Transfer processes from bench-scale to GMP manufacturing; support regulatory submissions.
• Lead and mentor scientists; ensure data management and project timelines.

Skills

Downstream process development

Purification optimization

Chromatography

Tangential Flow Filtration

Tech transfer to GMP

Project leadership

Troubleshooting

Education

PhD preferred in Chemical/Biochemical Engineering

MS in related field

Tools

AEX

SEC

HIC

TFF

Job description

Principal Engineer, Lentivirus Downstream Process Development

Somerset, New Jersey, United States

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 andother advanced cell therapy programs. The successful candidate will drive scientific excellence in downstreamprocessing (DSP)—including clarification, chromatography, TFF, sterile filtration and fill/finish—ensuringprocesses are robust, scalable, and phase-appropriate for GMP manufacturing. This position demands a blend ofhands-on technical mastery and strategic thinking to accelerate timelines while maintaining a patient-focusedapproach.

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.

#Li-JR1

#Li-Onsite

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.

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.

I (the candidate) enter into thisNon-Disclosure Agreement (the “Agreement”) with Legend Biotech USA Inc.(the “Company”), effective as of the date of my acknowledgement below, for the purpose of enabling the Company to evaluate a possible employment relationship with me.

• Access to Company Confidential Information. I acknowledge that for the sole and limited purpose of evaluating a possible employment relationship with me, the Company might disclose, or enable me to have access to, certain Confidential Information of the Company, as defined below. I agree that, except for purposes of evaluating a possible employment relationship with the Company or as expressly authorized in writing by the Company, I will (a)not use or disclose any Confidential Information; (b)keep all Confidential Information confidential at all times; and (c)not copy, reproduce or modify any Confidential Information.
• Definition of “Confidential Information.” For purpose of this Agreement, “Confidential Information” shall mean any and all information and materials provided to me by the Company, including without limitation, inventions, trade secrets, software code, product development and marketing strategies, ideas, processes, formulas, know-how, unpublished financial information, business plans, contractual relationships with third parties and operating strategies; memoranda, notes, records, drawings, manuals, disks, or other documents and media; and all embodiments, copies, extracts, and summaries thereof; provided, however, that “Confidential Information” shall not include information that: (a) is generally known or available to the public, or (b) is furnished to me by a third party who obtained such information using lawful means and without any restrictions on disclosure.
• Third Party Information. I agree that during the course of communications with the Company pursuant to this Agreement or in connection with my application and interviews for employment with the Company, I will not make any unauthorized use or disclosure to the Company of any confidential or proprietary information or trade secrets of any other person or entity to whom I have an obligation of confidentiality with respect to such information, including any current or former employer. I further agree not to provide to the Company any materials or documents of any third party that are not generally available to the public.
• Remedies for Breach. I acknowledge that in the event of any breach of this Agreement, the Company will not have an adequate remedy in money or damages, and therefore the Company shall be entitled to obtain temporary, preliminary and/or permanent injunctive relief to redress any such breach, from any court of competent jurisdiction, and that the Company’s right to obtain such relief shall not limit its right to obtain other available remedies.
• General. The interpretation and enforcement of this Agreement shall be governed by the laws of the State of California. This Agreement constitutes the entire agreement between the parties concerning the subject matters hereof; it supersedes any and all prior agreements or representations, written or oral, with respect to its subject matters; and it cannot be modified except in a written agreement signed by the Company.

Please print your name if you agree to the terms and conditions set forth in the applicant Non-Disclosure Agreement.