Downstream Process Development Scientist Jobs in New York

Legend Biotech is seeking a Sr. Scientist, Lentivirus Upstream Processing as part of the Technical Development team based in Somerset, NJ.

Role Overview

The Senior Scientist, Lentivirus Upstream Process Development, will be a core technical contributor responsible for designing, executing, and optimizing 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 apply technical expertise in upstream processing (USP)-including seed train optimization, mammalian cell culture (HEK293/HEK293T), large-scale transient transfection, and bioreactor scale-up-to ensure processes are robust, scalable, and phase-appropriate for GMP manufacturing. This position demands a blend of hands-on technical mastery and strong analytical thinking to support project timelines while maintaining a patient-focused approach.

Key Responsibilities

• Design and execute experimental strategies for lentiviral vector upstream production.
• Perform development and optimization of upstream processes, including seed train expansion, suspension mammalian cell culture (HEK293/HEK293T), plasmid transient transfection optimization, and feed batch/perfusion bioprocessing in stir-tank and rocker bioreactors.
• Support the establishment and validation of bioreactor scale-up and scale-down models to ensure process comparability and predictability.
• Support the translation of bench-scale processes to GMP manufacturing, assisting in technology transfer and providing troubleshooting support during clinical production runs.
• Execute study protocols to define operating parameters, feeding strategies, and performance limits; maintain accurate documentation for USP data.
• Communicate technical findings, issues, and potential delays to project leads in a timely manner.
• Collaborate with cross-functional team members, including CMC Project Management and other technical leads, to support project goals.
• Apply scientific knowledge and technology to optimize vector titer, specific productivity, and quality.
• Support team activities by providing technical guidance to junior staff, fostering a culture of scientific rigor and continuous improvement.
• Author and review technical documents, including development reports, SOPs, and relevant sections for regulatory submissions (IND).
• Work closely with Downstream Process Development and Analytical Development teams to ensure integrated process outcomes.
• Support tech transfer activities to/from other Legend sites or CDMOs.
• Ensure compliance with all internal and regulatory requirements.

Requirements

• Advanced degree (PhD preferred, or MS) in Chemical Engineering, Bioengineering, or a related field.
• Experience: 5-8 years (PhD) or 8+ years (MS) of experience in process development or manufacturing within a biotech or pharmaceutical setting
• Hands-on experience in mammalian cell culture (HEK293, HEK293T), seed train expansion, feeding strategy, and transient transfection optimization specifically for viral vectors (Lentivirus preferred).
• Demonstrated proficiency in developing and implementing bioreactor scale-up and scale-down models.
• Solid understanding of GMP manufacturing requirements and CMC strategies for early-phase clinical trials.
• Direct experience with cell and lentiviral vector technologies within the current emerging field.
• Working knowledge in engineering modeling, mass transfer, and bioprocess optimization.
• Strong interpersonal and communication skills; ability to maintain focus and collaborate effectively during challenging development timelines.
• Analytical and creative thinking.
• Effective 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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