Exceptional Release Specialist Jobs

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 Exceptional Release Specialist as part of the Technical Operations team based in Raritan, NJ.

Role Overview

Work with the Exceptional Release Expert to coordinate with the CAR-T MFG Site to provide all required information/ data and documentation related to Out-Of-Specification (OOS) batches to enable disposition determination with the objective to reduce / eliminate delay in release. Role will interface with Technical Support, Investigations, Batch Release, Medical Affairs, Vein-to-Vein teams to facilitate and improve the batch release for exceptional batches.

Key Responsibilities

• Support monitoring of performance indicators.
• Perform data gathering to provide information required to make a determination on next steps for the patient / batch. This includes but is not limited to Medical Affairs, Safety Team and Vein to Vein.
• Modify processes/procedures, as necessary, to ensure appropriate technical oversite of exceptional release.
• Participate as necessary in ad-hoc meetings to communicate relevant batch data, batch status, testing status etc with medical / safety teams.
• Support the Exceptional Release Expert in owning the OOS/Termination escalation process and coordinate with Vein-to-Vein team, Medical Affairs team, etc on remanufacturing strategy.
• Collaborate cross functionally to quickly escalate issues which may delay the release of a batch or require a remanufacture.
• Drive resolution of issues that may contribute to delays in release.
• Support monitoring the timeliness of the exceptional release and support adapting the process as necessary to improve overall workflow.

Requirements

• Demonstrated experience in leading cross-functional teams and responding to urgent issues.
• A minimum of six (5) years of professional relevant business experience.
• Knowledge and solid understanding of cGMP regulations and FDA/EU guidance.
• Ability to clearly explain technical details to diverse audiences.
• Ability to learn and operate various enterprise systems including eLIMS, TrackWise, Maximo, EMS, BMS, SAP.
• A minimum of a Bachelor’s degree in science, engineering or related field or equivalent experience required. Advanced degree preferred.
• Ability to coordinate cross functionally within the site and across the network.
• Excellent written and oral communication skills
• Support teams to troubleshoot and resolve technical problems.

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:

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