Legend Biotech
biotechnology
PrincipalScientist,UpstreamProcess,ProcessDevelopment
“Principal Scientist, Upstream Process, Process Development at Legend Biotech. Skills: Upstream Process Development, viral vector production, mammalian cell culture, bioreactor scale-up, lentivirus. Develop and optimize upstream processes for viral vector production. Implement state-of-the-art knowledge management for USP data”
What You'll Achieve.
maximize vector titer, specific productivity, and quality
Industry & Context.
troubleshooting skills; Resolve conflict and proactively identify/address performance issues
Onsite in Somerset, New Jersey
What They're Looking For.
Must Have
PhD or MS degree 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, 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, knowledge in engineering modeling, mass transfer, and bioprocess optimization, Excellent leadership, emotional intelligence, and communication ability to maintain composure and strategic focus during challenging development timelines, Creative, strategic thinking, troubleshooting skills
Nice to Have
PhD preferred, Mandarin is a plus, experience in handling large-scale (>50L, e. g. , 200L/500L) upstream bioreactor processes
What You'll Do.
Develop and optimize upstream processes for viral vector production
Implement state-of-the-art knowledge management for USP data
Communicate potential issues
and mitigation approaches
Identify project acceleration opportunities
Leverage advanced science and technology to maximize vector titer
specific productivity
Identify creative solutions to define unknowns in the viral vector production field
Guide a team of scientists in the execution of project-specific activities
Author and serve as a primary reviewer for technical documents
including development reports
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
How You'll Work.
Team & Collaboration
Collaborate with Senior Leaders, CMC Project Manager, Project Leader, and other technical leads; Work closely with Downstream Process Development and Analytical Development teams; Tech transfer process to/from other Legend sites or CDMOs
Communication Scope
Excellent leadership, emotional intelligence, and communication ability; Communicate the potential for issues and delays along with solutions and mitigation approaches
Process & Methodology
Identify project acceleration opportunities, Manage challenging development timelines
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