Change Control Specialist

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 Change Control Specialist as part of the Technical Operations team based in Raritan. 

Role Overview

The Change Control Specialist will be part of the Technical Operations team and will be responsible for change control support for the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment

Key Responsibilities  

• Support process changes arising from updates to materials, excipients or finished goods requirements.
• Support efforts to establish and streamline the site change control process.
• Act as change control champion for operations by owning the change control from Initiation through completion.
• Participate in global forums/team meetings for change control.
• Run reports and conduct data analysis to support establishment and monitoring of change control for operations.
• Lead cross functional team meetings to prioritize updates to MBRs/ EBR/MES updates.
• Manage implementation of corrections / CPAs by working with SMEs, Correction/ CPA owners, and tech writers to maintain timelines.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Drive change controls to ensure on time completion and ensure change controls are executed in compliance with applicable policies and procedures. 

• A minimum of a Bachelor’s degree in engineering, biology, chemistry or related field or equivalent experience required. Advanced degree preferred.
• 6 years of operations experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred.
• Ability to coordinate and drive projects to completion.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
• Build strong partnerships with Manufacturing, Engineering and Quality to ensure integration and collaboration of change requirements.
• Prior experience with CAR-T and/or cell therapy is highly desired.
• Experience in the Pharmaceuticals or related industry is required.
• Strong working knowledge of current Good Manufacturing Practices (cGMP’s), initiating and executing change controls is required.
• Strong project management skills desired.
• Demonstrated technical leadership within pharmaceutical or similar environment is highly desired.
• Experience with the start-up of new biopharmaceutical manufacturing facilities is preferred.
• Experience with Trackwise or equivalent systems is highly desired.
• Proficiency in English (verbal and written), strong communication skills and the ability to influence at all levels are required.
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint and Outlook) is required.
• Ability to accommodate changes in the schedule including working in other shifts as per operational needs is required.
• This position will be based in Raritan, NJ and requires up to five percent (5%) of domestic and international travel.

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.