Validation Lifecycle & Technical Lead

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Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

This position represents a critical support role in the global MSAT organization. This individual will support global process validation activities in support of the commercial Carvykti program both within Legend and also externally with our program partner Janssen. The effort will extend to participation in a variety of cross‑functional CMC and quality forums under the Joint Manufacturing Committee in the commercial governance structure.

The candidate will also collaboratively work within identified sub‑teams to develop best practices for global initiatives in validation, quality compliance and material/ raw material support. The validation scope comprises a multi‑site global manufacturing network responsible for manufacturing an approved cell therapy product in the Multiple Myeloma space, including validation, data analytics and commercial support. The Quality Compliance scope includes working on quality‑related sub‑teams such as change control sub‑teams and investigational sub‑teams.

The material/ raw material scope includes working both internally and with external partners to track changes to our material/ raw material program and develop best practices for evaluation of changes to the same and their impact on the Carvykti product. Stakeholder management is required to drive and implement documentation template efforts worldwide as part of collaborative working groups and cross‑functional partners.

• Integrate into appropriate sub‑teams particularly validation, data analytics (including CPV), quality compliance (including change control and investigations), and material/ raw material sub‑teams to support global best practices
• Partner closely with Legend and Janssen partners to complete supporting technical documentation with an eye for global alignment templates
• Work collaboratively with internal and external partners to drive and establish cell therapy standards, policies, procedures across the validation lifecycle
• Align global documentation strategy
• Provide input and review for validation documents including master plans, PPQ and comparability protocols and reports
• Serve as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change controls, draft industry guidelines, specification & critical limits
• Develop and align a variety of process validation documentation templates ranging from control strategies to PVP and PPQ templates
• Support global initiatives related to quality/compliance/validation (APS benchmarking, Validation Lifecyle Responsibilities, OOS monitoring and trending program)
• Contribute to developing and/or improvements to quality systems in support of global implementation of changes (e.g., process and material changes)

• B.S. required.
• Minimum 5 years of industrial biologics experience, CAR‑T experience is highly desirable.
• Candidate must have experience in Cell Therapy, MSAT and/or Quality/Compliance (particularly in material/ raw material enrollment and release).
• Experience in a cross‑functional commercial team in driving global programs and/or…