Role OverviewThe 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. This role ensures robust, scalable, and compliant manufacturing processes for viral vector platforms that can be transferred to internal or external sites. This role requires collaboration and partnering closely with Process Development, Manufacturing, Quality, Regulatory, and Supply Chain teams 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 for assigned viral vector platforms, including upstream production, downstream purification, formulation, and fill/finish interfaces.
- Lead technology transfer of viral vector processes from Process Development into GMP manufacturing, including internal sites and external CDMOs.
- Serve as the primary MSAT technical lead for deviations, root cause investigations, risk assessments, and CAPA execution.
- Drive process characterization, control strategy development, continued process verification (CPV), and performance trending.
- Partner cross-functionally to identify and 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 a team of MSAT scientists and engineers.
- Drives justification and alignment with key partners (ie. JnJ).
Requirements- B.S. required, in technical discipline: biology, engineering, science, or related field.
- Minimum 10 years of in MSAT, tech transfer or process development.
- Industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable.
- Experience in cell therapy commercial cGMP program with end-to-end know-how to manage process platform changes/improvements in a global manufacturing network and change management process.
- Candidate must have extensive experience in Cell Therapy tech transfer and/or MSAT.
- Experience in a cross functional CMC team as a technical representative driving global commercial programs in cell therapy.
- Experience as a technical owner in reviewing regulatory submission sections, responding to agency audits.
- Experience in implementing and managing new commercial processes, improvements and changes.
- Experience in driving consistency across multiple manufacturing sites.
- Experience in collaborating with external partners and CMOs preferred.
- Extensive knowledge in process development, technology transfer, process comparability, CMC regulatory guidelines, process monitoring and manufacturing operations support.
- Ability to think critically and demonstrated troubleshooting and problem-solving skills.
- Results driven with strong analytical, problem solving and critical thinking skills.
- Strong experience working in a cross-functional organization with multiple partners with competing priorities.
- Ability to plan, multitask, prioritize and be an effective and influential decision maker focused on action and implementation.
#Li-BZ1
#Li-Hybrid
Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech. 
