Legend Biotech US
Principal Engineer, Lentivirus Downstream Process Development
Somerset, New Jersey, United States · Principal
Sponsorship not specified$146k-$192kDetected 1 day ago
Project ManagementSignal ProcessingGMPAnimal StudiesLeadershipCommunicationCollaboration
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About the role
- The Principal Engineer, Lentivirus Downstream Process Development, will be a key technical leader responsible for designing, optimizing, and scaling purification processes for lentiviral vectors (LVV) within our
- This position demands a blend of hands-on technical mastery and strategic thinking to accelerate timelines while maintaining a patient-focused approach.
Responsibilities
- Design and execute highly efficient purification strategies for lentiviral vectors, specifically optimized for CAR-T applications.
- 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.
- In collaboration with the Senior Leaders, CMC Project Manager, Project Leader, and other technical leads identify project acceleration opportunities.
- Author and serve as a primary reviewer for technical documents, including development reports, SOPs, and CMC sections for regulatory submissions (IND/IMPD).
Requirements
- 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.
- Strong understanding of GMP manufacturing requirements and CMC strategies for early-phase clinical trials.
Nice to have
- Advanced degree (PhD preferred, or MS) in Chemical Engineering, Biomedical Engineering, bioprocessing engineering or a related field.
- Deep technical hands-on experience in purification, chromatography, and TFF specifically for viral vectors (Lentivirus preferred).
- Preferred experience in handling large scale(>50L) purification process.
Skills
- Provide hands-on training as needed.
- Communicate the potential for issues and delays along with solutions and mitigation approaches.
- 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.
Compensation
- $146,410 - $192,164 USD
- Pay Range (Base Pay):
Benefits
- Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
Company info
- Legend Biotech is seeking a Principal Engineer, Lentivirus Downstream Process Development as part of the Technical Development team based in Somerset, NJ.
- 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.
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