Global Viral Vector MSAT Lead
Legend Biotech
11 days ago
Remote friendly (Raritan, NJ)
United States
Operations
Role Overview:
Senior Manager, MSAT – Viral Vector Lead for 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, and compliant manufacturing processes for viral vector platforms that can be transferred to internal or external sites. Collaborates with Process Development, Manufacturing, Quality, Regulatory, and Supply Chain to enable reliable clinical supply and future commercialization.
Key Responsibilities:
- Lead MSAT technical support for clinical and late-stage GMP manufacturing of viral vectors for in vivo platforms.
- Own end-to-end process knowledge (upstream production, downstream purification, formulation, and fill/finish interfaces).
- Lead technology transfer of viral vector processes into GMP manufacturing (internal sites and external CDMOs).
- Serve as primary MSAT technical lead for deviations, root cause investigations, risk assessments, and CAPA execution.
- Drive process characterization, control strategy development, CPV, and performance trending.
- Identify/mitigate manufacturing, scale-up, and comparability risks to ensure supply continuity.
- Provide MSAT technical input to CMC regulatory submissions, health authority interactions, and inspection readiness.
- Lead, mentor, and develop an MSAT team.
- Align/justify with key partners.
Requirements:
- B.S. in biology, engineering, science, or related field.
- Minimum 10 years in MSAT, tech transfer, or process development.
- Industrial biologics CMC development or manufacturing experience; CAR-T experience highly desirable.
- Experience in cell therapy commercial cGMP programs; end-to-end change/improvement management in a global manufacturing network.
- Extensive experience in cell therapy tech transfer and/or MSAT.
- Cross-functional CMC experience as a technical representative.
- Experience reviewing regulatory submissions and responding to agency audits.
- Experience implementing/managing new commercial processes and changes.
- Experience driving consistency across multiple manufacturing sites.
- External partner/CMO collaboration experience preferred.
- Extensive knowledge of process development, technology transfer, comparability, CMC guidelines, process monitoring, and manufacturing operations support.
- Strong troubleshooting, analytical, and critical-thinking skills.
- Ability to plan, multitask, prioritize, and make effective decisions in a fast-paced cross-functional environment.
Senior Manager, MSAT – Viral Vector Lead for 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, and compliant manufacturing processes for viral vector platforms that can be transferred to internal or external sites. Collaborates with Process Development, Manufacturing, Quality, Regulatory, and Supply Chain to enable reliable clinical supply and future commercialization.
Key Responsibilities:
- Lead MSAT technical support for clinical and late-stage GMP manufacturing of viral vectors for in vivo platforms.
- Own end-to-end process knowledge (upstream production, downstream purification, formulation, and fill/finish interfaces).
- Lead technology transfer of viral vector processes into GMP manufacturing (internal sites and external CDMOs).
- Serve as primary MSAT technical lead for deviations, root cause investigations, risk assessments, and CAPA execution.
- Drive process characterization, control strategy development, CPV, and performance trending.
- Identify/mitigate manufacturing, scale-up, and comparability risks to ensure supply continuity.
- Provide MSAT technical input to CMC regulatory submissions, health authority interactions, and inspection readiness.
- Lead, mentor, and develop an MSAT team.
- Align/justify with key partners.
Requirements:
- B.S. in biology, engineering, science, or related field.
- Minimum 10 years in MSAT, tech transfer, or process development.
- Industrial biologics CMC development or manufacturing experience; CAR-T experience highly desirable.
- Experience in cell therapy commercial cGMP programs; end-to-end change/improvement management in a global manufacturing network.
- Extensive experience in cell therapy tech transfer and/or MSAT.
- Cross-functional CMC experience as a technical representative.
- Experience reviewing regulatory submissions and responding to agency audits.
- Experience implementing/managing new commercial processes and changes.
- Experience driving consistency across multiple manufacturing sites.
- External partner/CMO collaboration experience preferred.
- Extensive knowledge of process development, technology transfer, comparability, CMC guidelines, process monitoring, and manufacturing operations support.
- Strong troubleshooting, analytical, and critical-thinking skills.
- Ability to plan, multitask, prioritize, and make effective decisions in a fast-paced cross-functional environment.