Location: Raritan,NJ, USA
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 QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ.
Role Overview
The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process, equipment, and associated deviations and investigations within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They will be a subject matter expert for the manufacturing process and provide front line support to address and resolve manufacturing issues.
Key Responsibilities
* Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of manufacturing operations and technical activities
* Provide expertise and solutions to issues related to investigations and deviations occurring during routine manufacturing and protocol driven activities such as tech transfer and process validation
* Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for manufacturing operations
* Assist in the development of process, operational, and quality improvements for manufacturing
* Support manufacturing and technical operations teams in trouble shooting and resolving complex scientific / technical problems
* Develops and evaluates quality processes and system standards to ensure compliance with applicable Janssen standards, industry standards, and global regulations.
* Provide Quality Oversight for batch records, change controls, SOPs, non-conformances, risk assessments, and CAPAs associated with manufacturing and technical operations and ensure effectiveness of related actions.
* Point of contact for technical and manufacturing operations for quality oversight
* Ability to work independently and successfully prioritize multiple tasks simultaneously
* Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.
* Drive continuous improvement
* Other duties may be assigned, as necessary.
Requirements
* A minimum of a Bachelor's Degree in Science or equivalent technical discipline is required
* A minimum of 8 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, MSAT or cell therapy. A portion of the 8 years must include MSAT experience.
* Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience in supporting cell-based products is a plus
* Strong knowledge of cell therapy process preferred
* Experience in cGMP regulatory body audits
* Strong interpersonal and written/oral communication skills
* Ability to quickly process complex information and make critical decisions with limited information
* Ability to work independently and be responsible for a portfolio of ongoing projects
* Ability to pay attention to details and follow procedures closely
* Ability to identify and assess possible gaps and work collaboratively to address such issues
* Must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision
* Experience reviewing/auditing GMP documentation
* Strong proficiency with using Microsoft Office applications
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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.