Validation Lifecycle & Technical Lead

Role Overview

This position represents a critical support role in the global MSAT organization. This individual will be responsible to support global process validation activities in support of the commercial Carvykti program both within Legend but also externally with our program partner Janssen. This 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 be required to 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.

Key Responsibilities  

• 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

Requirements

• 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 initiatives.
• Experience in developing, writing and approving technical documents.
• Experience with Quality systems (Change control, investigations, LIMs, etc.).
• Extensive technical writing experience.
• Knowledge in cell therapy validation industry best practices is highly preferred.
• Ability to think critically and demonstrated troubleshooting and problem-solving skills.
• Results driven with strong analytical, problem solving and critical thinking skills.
• Experience working in a cross-functional organization with multiple partners with competing priorities.

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