The Associate Director, Manufacturing Operations Lead will be responsible for performing the activities necessary to start up and run a new in-house GMP facility and deliver Phase 1 clinical trial material for several cell therapy pipeline assets to patients in need. The successful candidate will first collaborate with a cross-functional team including development, quality, IT, facilities, safety, and operations to establish the systems necessary to operate the facility for the purpose of produc... more details
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 an Associate Director, Manufacturing Operations Lead as part of the Technical Development team based in Somerset, NJ.
Role Overview
The Associate Director, Manufacturing Operations Lead will be responsible for performing the activities necessary to start up and run a new in-house GMP facility and deliver Phase 1 clinical trial material for several cell therapy pipeline assets to patients in need. The successful candidate will first collaborate with a cross-functional team including development, quality, IT, facilities, safety, and operations to establish the systems necessary to operate the facility for the purpose of producing Phase 1 products. The following activities will include implementing manufacturing, testing and release for cell therapy product candidates.
Key Responsibilities
Create procedures necessary to operate the GMP facility in a Phase 1 manner
In collaboration with the development and quality teams, define the layout and activity flow for the facility along with appropriate classification
Establish relationships with outsourced vendors such as environmental monitoring
Establish a training program for all staff performing GMP activities
Lead a cross-functional team to design and perform qualification activities such as aseptic process simulations, equipment qualification, etc.
Participate in project teams to design and execute process and analytical method transfer
Participate in project teams to design and deliver IND-enabling data for each cell therapy asset
Direct routine manufacturing and testing of cell therapy products in collaboration with related functions including development, quality, IT, facilities, safety, and operations
Ensure the required quality and safety standards are achieved and maintained with respect to GMP operating procedures, batch manufacturing documentation, GMP suites and compliance with the relevant phase-specific regulatory requirements
Requirements
BS in cell biology, molecular biology, immunology, microbiology, biomedical engineering or other related sciences preferred.
Knowledge and experience with cell therapy manufacturing processes and tests
Experience establishing and operating in a GMP environment
Familiarity with cell therapy manufacturing and testing equipment
Pragmatism in applying GMP in a phase-specific manner in the best interest of the patient
Experience working in cross-functional matrices
Excellent collaboration skills
Ability to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment
Familiarity with aseptic processing
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.
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
We would like to take a second to Welcome You to Job Abstracts, the nation’s largest Pure Job Board. With over 3.1 million job listings from 15,000+ Companies & Organizations, we help job searchers find careers that match their interests. As an anonymous user, you have probably discovered how easy our system is to use. However, you have just scratched the surface of what we can offer.
We encourage you to Register so you can use our most powerful features: searching with multiple terms, setting up multiple locations, establishing favorite companies, and accessing your search history. If you find a job you like, you can apply directly for it, and then, keep notes on it. We will also keep a lookout for jobs that match your search terms and email you when we find something you may like.
You can register for free and the system is free to use. If you like our system so far, click on Register and unlock the power required by serious job searchers.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.
