Global Viral Vector MSAT Lead
Legend Biotech
August 21, 2026
On-site
Raritan, NJ
Operations
Role Overview
Senior Manager, MSAT – Viral Vector Lead (Global In Vivo platforms) provides technical leadership and execution oversight for viral vector manufacturing supporting in vivo programs across clinical development and commercial lifecycle management. Ensures robust, scalable, compliant viral vector manufacturing processes transferable to internal or external sites, partnering with Process Development, Manufacturing, Quality, Regulatory, and Supply Chain.
Key Responsibilities
- Lead MSAT technical support for clinical and late-stage GMP viral vector manufacturing for in vivo platforms.
- Own end-to-end platform process knowledge: upstream, downstream, purification, formulation, and fill/finish interfaces.
- Lead technology transfer into GMP manufacturing (internal sites and external CDMOs).
- Primary technical lead for deviations, root cause investigations, risk assessments, and CAPA execution.
- Drive process characterization, control strategy development, CPV, and performance trending.
- Mitigate manufacturing/scale-up/comparability risks to ensure supply continuity.
- Provide MSAT input to CMC regulatory submissions, health authority interactions, and inspection readiness.
- Lead, mentor, and develop MSAT scientists and engineers.
- Drive justification and alignment with key partners (e.g., JnJ).
Requirements
- B.S. in biology, engineering, science, or related field.
- Minimum 10 years in MSAT, tech transfer, or process development.
- Industrial biologics CMC development/manufacturing; CAR-T experience highly desirable.
- Experience in cell therapy commercial cGMP; manage platform changes/improvements globally.
- Extensive cell therapy tech transfer and/or MSAT experience.
- Cross-functional CMC experience as technical representative for global programs.
- Experience reviewing regulatory submission sections and responding to agency audits.
- Experience implementing new commercial processes/improvements/changes; drive consistency across multiple sites.
- Ability to collaborate with external partners/CMOs preferred.
- Strong knowledge of process development, tech transfer, comparability, CMC guidelines, monitoring, and manufacturing operations support.
- Critical thinking, troubleshooting, analytical/problem-solving skills; plan/prioritize and influence decisions.
Benefits (explicitly stated)
- Medical, dental, vision; 401(k) with company match; 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, 11 company holidays).
- Other voluntary benefits listed (flexible spending/HSAs, life/AD&D, short-/long-term disability, legal assistance, supplemental plans, commuter benefits, care resources, well-being initiatives, recognition programs).
Application Instructions
- Applicants must be authorized to work in the United States; employment eligibility verified via E-Verify (Form I-9 required if selected).
Senior Manager, MSAT – Viral Vector Lead (Global In Vivo platforms) provides technical leadership and execution oversight for viral vector manufacturing supporting in vivo programs across clinical development and commercial lifecycle management. Ensures robust, scalable, compliant viral vector manufacturing processes transferable to internal or external sites, partnering with Process Development, Manufacturing, Quality, Regulatory, and Supply Chain.
Key Responsibilities
- Lead MSAT technical support for clinical and late-stage GMP viral vector manufacturing for in vivo platforms.
- Own end-to-end platform process knowledge: upstream, downstream, purification, formulation, and fill/finish interfaces.
- Lead technology transfer into GMP manufacturing (internal sites and external CDMOs).
- Primary technical lead for deviations, root cause investigations, risk assessments, and CAPA execution.
- Drive process characterization, control strategy development, CPV, and performance trending.
- Mitigate manufacturing/scale-up/comparability risks to ensure supply continuity.
- Provide MSAT input to CMC regulatory submissions, health authority interactions, and inspection readiness.
- Lead, mentor, and develop MSAT scientists and engineers.
- Drive justification and alignment with key partners (e.g., JnJ).
Requirements
- B.S. in biology, engineering, science, or related field.
- Minimum 10 years in MSAT, tech transfer, or process development.
- Industrial biologics CMC development/manufacturing; CAR-T experience highly desirable.
- Experience in cell therapy commercial cGMP; manage platform changes/improvements globally.
- Extensive cell therapy tech transfer and/or MSAT experience.
- Cross-functional CMC experience as technical representative for global programs.
- Experience reviewing regulatory submission sections and responding to agency audits.
- Experience implementing new commercial processes/improvements/changes; drive consistency across multiple sites.
- Ability to collaborate with external partners/CMOs preferred.
- Strong knowledge of process development, tech transfer, comparability, CMC guidelines, monitoring, and manufacturing operations support.
- Critical thinking, troubleshooting, analytical/problem-solving skills; plan/prioritize and influence decisions.
Benefits (explicitly stated)
- Medical, dental, vision; 401(k) with company match; 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, 11 company holidays).
- Other voluntary benefits listed (flexible spending/HSAs, life/AD&D, short-/long-term disability, legal assistance, supplemental plans, commuter benefits, care resources, well-being initiatives, recognition programs).
Application Instructions
- Applicants must be authorized to work in the United States; employment eligibility verified via E-Verify (Form I-9 required if selected).