Principal Engineer, Lentivirus Downstream Process Development
Legend Biotech
August 25, 2026
On-site
Somerset, NJ
Operations
Principal Engineer, Lentivirus Downstream Process Development (Somerset, NJ)
Role Overview
Design, optimize, and scale lentiviral vector (LVV) purification processes for cell therapy pipelines, integrating modeling/analytics into downstream workflows and enabling robust, phase-appropriate GMP manufacturing.
Key Responsibilities
- Build mechanistic/hybrid in silico models; use model-first and AI-enabled development strategies.
- Apply mass transfer, fluid mechanics, and thermodynamics to LVV purification models.
- Use ML for modeling/clustering to generate process insights.
- Develop/optimize downstream processes: clarification (depth filtration, centrifugation), chromatography (AEX, SEC, HIC), and TFF for concentration/diafiltration.
- Translate bench-scale to GMP via simulation + wet lab; support technology transfer and clinical troubleshooting.
- Design Advanced Process Control (e.g., MPC, state estimators) to optimize performance.
- Identify acceleration opportunities, communicate risks/delays with mitigations, and resolve performance issues.
- Lead scientists’ execution; author/review technical documents (development reports, SOPs, IND/IMPD CMC sections).
- Coordinate with Upstream Process Development and Analytical Development; perform site/CDMO tech transfer.
- Ensure regulatory compliance.
Requirements
- PhD (preferred) or MS in Chemical/Biomedical/Bioprocess Engineering or related field.
- 8+ years (PhD) or 10+ years (MS) in biotech/pharma process development/manufacturing.
- Modeling/simulation knowledge; Python and MATLAB; deep LVV purification (chromatography, TFF).
- Strong GMP/CMC understanding for clinical phases; advanced knowledge of lentiviral vector technologies.
- Leadership, communication, troubleshooting, creative/strategic thinking.
Preferred
- Processes tailored for in vivo CAR-T/systemic delivery; large-scale (>50 L) purification; Mandarin.
Benefits (as stated)
Medical/dental/vision; 401(k) with company match; 8 weeks paid parental leave; PTO (vacation/personal/sick/floating) plus 11 holidays.
Pay Range (Base)
$146,410–$192,164.
Role Overview
Design, optimize, and scale lentiviral vector (LVV) purification processes for cell therapy pipelines, integrating modeling/analytics into downstream workflows and enabling robust, phase-appropriate GMP manufacturing.
Key Responsibilities
- Build mechanistic/hybrid in silico models; use model-first and AI-enabled development strategies.
- Apply mass transfer, fluid mechanics, and thermodynamics to LVV purification models.
- Use ML for modeling/clustering to generate process insights.
- Develop/optimize downstream processes: clarification (depth filtration, centrifugation), chromatography (AEX, SEC, HIC), and TFF for concentration/diafiltration.
- Translate bench-scale to GMP via simulation + wet lab; support technology transfer and clinical troubleshooting.
- Design Advanced Process Control (e.g., MPC, state estimators) to optimize performance.
- Identify acceleration opportunities, communicate risks/delays with mitigations, and resolve performance issues.
- Lead scientists’ execution; author/review technical documents (development reports, SOPs, IND/IMPD CMC sections).
- Coordinate with Upstream Process Development and Analytical Development; perform site/CDMO tech transfer.
- Ensure regulatory compliance.
Requirements
- PhD (preferred) or MS in Chemical/Biomedical/Bioprocess Engineering or related field.
- 8+ years (PhD) or 10+ years (MS) in biotech/pharma process development/manufacturing.
- Modeling/simulation knowledge; Python and MATLAB; deep LVV purification (chromatography, TFF).
- Strong GMP/CMC understanding for clinical phases; advanced knowledge of lentiviral vector technologies.
- Leadership, communication, troubleshooting, creative/strategic thinking.
Preferred
- Processes tailored for in vivo CAR-T/systemic delivery; large-scale (>50 L) purification; Mandarin.
Benefits (as stated)
Medical/dental/vision; 401(k) with company match; 8 weeks paid parental leave; PTO (vacation/personal/sick/floating) plus 11 holidays.
Pay Range (Base)
$146,410–$192,164.