Principal Scientist, Upstream Process, 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 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 Scientist Lentivirus Upstream Process Development as part of the Technical Development team based in Somerset NJ.

Role Overview

The Principal Scientist Lentivirus Upstream Process Development will be a key technical leader responsible for designing optimizing and scaling upstream production processes for lentiviral vectors (LVV) within our innovative pipeline. This role focuses on delivering high-quality high-titer vector products to support LVV generation and other advanced cell therapy programs. The successful candidate will drive scientific excellence in upstream processing (USP)including seed train optimization mammalian cell culture (HEK293 and HEK293T) large-scale transient transfection and bioreactor scale-up and scale-down modelensuring 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 upstream production strategies for lentiviral vectors.
• Direct the development and optimization of upstream processes including but not limited to: seed train expansion suspension mammalian cell culture (HEK293/HEK293T) plasmid transient transfection optimization and feed batch/perfusion bioprocessing in stir-tank and rocker bioreactors.
• Establish and validate robust bioreactor scale-up and scale-down models to ensure process comparability and predictability across different manufacturing scales.
• Direct the translation of bench-scale processes to GMP manufacturing ensuring seamless technology transfer and providing troubleshooting support during clinical production runs.
• Provide hands-on training as needed.
• Lead the execution of study protocols to define operating parameters feeding strategies and performance limits; implement state-of-the-art knowledge management for USP 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 titer specific productivity and quality identifying creative solutions to define unknowns in the viral vector production 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).
• Work closely with Downstream 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 Virology Molecular Biology or a related field.
• 8 years (PhD) or 10 years (MS) of experience in process development or manufacturing within a biotech or pharmaceutical setting
• Deep technical hands-on experience in mammalian cell culture (HEK293 HEK293T) seed train expansion feeding strategy and transient transfection optimization specifically for viral vectors (Lentivirus preferred).
• Proven expertise in developing and implementing bioreactor scale-up and scale-down models.
• 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
• Strong knowledge in engineering modeling mass transfer and bioprocess optimization.
• 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 handling large-scale (>50L e.g. 200L/500L) upstream bioreactor processes.
• Language(s): English. Mandarin is a plus.
  
  

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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.