Director, Global Process Validation

Company Information

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 and natural killer (NK) cell-based immunotherapy.

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) in 2017. 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.

Legend Biotech is seeking Director, Global Process Validation as part of the Technical Operations team based in Raritan, NJ.

Role Overview

This position represents a critical leadership role in the global MSAT organization. This individual will be responsible for 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 forum under the Joint Manufacturing Committee in the commercial governance structure. The candidate will also be required to build and manage a team of experienced cell therapy professionals whose responsibility it is to deliver a best-in-class high volume marketed CAR-T product. The validation scope comprises a multi-site global manufacturing network responsible for manufacturing an approved cell therapy product in the Multiple Myeloma space. This individual is required to drive the success and overall sustainability of global validation program by adhering to industry best practices and sound cell therapy technical principles to ensure that the commercial process is maintained in a validated and controlled state and consistently delivers quality product meeting or exceeding the standard of various health authorities. Stakeholder management is required to drive and implement process validation program efforts worldwide as part of collaborative working groups and cross functional partners.

Key Responsibilities

• Represent MSAT at joint quality and CMC committees
• Partner closely with senior Janssen leadership to achieve global alignment on all validation Carvykti scope
• Provide organizational leadership and support of an expanding global manufacturing network for best-in-class CAR-T product.
• Work collaboratively with internal and external partners to drive and establish cell therapy standards, policies, procedures across the validation lifecycle
• Align global process validation strategy, comparability plans and data governance initiatives
• Provide critical input and review for validation 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
• Serves as validation SME for Health Authority inspections and contributes to follow-up actions as part of an audit response team
• Develop and align a variety of process validation documentation templates ranging from control strategies to PVP and PPQ templates
• Serve as an SME for global initiatives related to quality/compliance/validation (APS benchmarking, Validation Lifecyle Responsibilities, OOS monitoring and trending program)
• Contribute to developing and/or improvements to analytics/reporting tools and systems in support of global data systems and regulations (i.e.. datalake, 21CFRPart11 systems, front end reporting tools and templates)
• Provide key input on standard approaches specific to cell therapy products (i.e. modified Nelson rules, Equivalence vs. Expectation)
  
  
  

Requirements

• B.S. required, Ph.D. preferred in technical discipline: engineering, science, or related field
• Minimum 10 years of industrial biologics process validation experience, CAR-T experience is highly desirable.
• Extensive experience in an approved cell therapy program with end-to-end know-how in support of validation in a global manufacturing network
• Candidate must have extensive experience in Cell Therapy tech transfer and/or MSAT.
• Experience in a cross functional commercial team in driving global programs and/or initiatives
• Experience in implementing and managing commercial process validation scope and defending this to a variety of health authorities
• Experience in driving consistency across multiple manufacturing sites
• Extensive knowledge in cell therapy validation industry best practices.
• 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.
  
  
  

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.

Benefits:

• Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Matched 401K
• Flexible Spending Account
• Health Savings Account
• AD&D Insurance
• Short-Term Disability
• Long-Term Disability
• Paid Maternity Leave
• Paid Paternity Leave
• Pet Insurance
• Critical Illness Insurance
• Hospital Indemnity Insurance
• Accident Insurance
• Legal Insurance
• Commuter Benefits
• Employee Assistance Program