Legend Biotech
Biotechnology
ScientistI,ProcessDevelopment
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Scientist I, Process Development at Legend Biotech. Skills: Process development, Bioprocessing, Cell therapy manufacturing, GMP. Participate in activities aligned with organizational workflow. Execute bioprocess development studies”
Industry & Context.
Engineering problem solving; Root cause investigations; Complex bioprocessing problems
Evening and weekend work, Evening work, Weekend work
What They're Looking For.
Must Have
BS with 3-5 years experience, MS with 2-3 years experience, PhD with 1-2 years experience, Core engineering background in bioprocessing, Experience in biotechnology bioprocessing, Hands-on experience with bioreactors, Experience handling cell processing, Proven experience authoring SOPs/procedures, Ability to transfer bioprocesses, Ability to manage shifting priorities, Ability to work collaboratively, Expertise in engineering problem solving, Solid decision-making abilities
Nice to Have
Technical training / certification is desirable, Proficiency in cGMP and FDA guidelines is preferred
What You'll Do.
Participate in activities aligned with organizational workflow
Execute bioprocess development studies
Interpret process development experiment results
Execute bespoke manufacturing process
Document procedure on Master Batch Records
Author technical protocols
Author technical reports
Maintain accurate lab notebooks
Maintain manufacturing records
Manage records for maintenance
Manage records for calibration
Manage records for cleaning
Manage records for operation
Lead effort to maintain laboratory inventories
Provide technical support
Provide engineering expertise
Support manufacturing root cause investigations
Analyze process development data
Organize process development data
Analyze manufacturing data
Organize manufacturing data
Work collaboratively with teams
Support establishment of development strategies
Supply materials for pre-clinical studies
Solve complex bioprocessing problems
How You'll Work.
Team & Collaboration
Cross-functional teams; EDD; Analytical Development; Material Science; Engineering teams; Manufacturing teams; Analytical teams
Communication Scope
Technical documentation
Full 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 participate in activities aligned with organizational workflow and procedures. Ability to execute bioprocess development studies in the lab (including bioreactor runs, upstream engineering, and downstream processing), document the procedure, and interpret process development experiment results. Ability to execute the bespoke manufacturing process in the GMP suite, and document the procedure on Master Batch Records (MBRs) in a GMP-compliant environment. Author technical protocols, technical reports, SOPs, and MBRs for upstream, downstream, and cell therapy manufacturing processes. Ability to maintain accurate and updated lab notebooks and manufacturing records. Work within the team to manage equipment (such as bioreactors and purification systems) and records for maintenance, calibration, cleaning, and operation, and lead the effort to maintain laboratory inventories. Provide technical support and engineering expertise as a Subject Matter Expert (SME) for manufacturing root cause investigations for Deviations and CAPA. Ability to use engineering and statistical tools to analyze and organize process development and manufacturing data with scientific integrity, and in a clear and concise manner. Ability to work collaboratively with the EDD, Analytical Development, Material Science, and other cross-functional teams to support the establishment of development strategies for new biological/cell products and supply materials to support pre-clinical studies and associated activities. Ability to use professional concepts in accordance with company objectives to solve comple
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