Global Viral Vector MSAT Lead

BioSpace; Raritan (NJ); On-site; USD 146,000 - 192,000; Full time

Job summary

Legend Biotech seeks a Senior Manager, MSAT - Viral Vector Lead to provide technical leadership for viral vector manufacturing supporting in vivo programs across clinical and commercial lifecycles. This role ensures scalable, compliant processes and partners with Process Development, Manufacturing, Quality, Regulatory, and Supply Chain to enable reliable clinical supply and future commercialization.

The candidate will own end-to-end process knowledge, lead tech transfer, manage deviations and

Qualifications

• B.S. in a technical discipline is required.
• Minimum 10 years in MSAT, tech transfer or process development.
• Industrial biologics CMC development/manufacturing experience is required; CAR-T experience is highly desirable.
• Experience in cell therapy commercial cGMP programs with end-to-end know-how for global changes.
• Experience as a technical owner in regulatory submissions and agency audits.
• Experience collaborating with external partners and CMOs is preferred.

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 viral vector platforms including upstream/downstream/formulation/fill-finish.
• Lead tech transfer of viral vector processes from Process Development into GMP manufacturing (internal sites & CDMOs).
• Serve as MSAT technical lead for deviations, investigations, risk assessments, CAPA.
• Drive CPV, process characterization, control strategy development, and performance trending.
• Mentor and develop a team of MSAT scientists and engineers.
• Collaborate with partners to ensure supply continuity and regulatory readiness.

Skills

MSAT leadership

Tech transfer

Cross-functional collaboration

Analytical thinking

Problem solving

Education

B.S. in biology/engineering/science

Job description

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Global Viral Vector MSAT Lead

Role Overview

The 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.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. 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. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay)

$146,410 - $192,164 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

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