This position represents a critical technical role supporting analytical automation efforts within the global MSAT organization. This individual will be responsible for the technical and program management scope to drive activities ranging from strategic/business plans, to managing all activities to implement a successful analytical automation platform for the commercial Carvykti program. Specifically, this effort will include scope related to both flow and plate based analytical assays and will...
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 Analytical Automation Consultant as part of the Global MSAT team based in Raritan, NJ.
Role Overview
This position represents a critical technical role supporting analytical automation efforts within the global MSAT organization. This individual will be responsible for the technical and program management scope to drive activities ranging from strategic/business plans, to managing all activities to implement a successful analytical automation platform for the commercial Carvykti program. Specifically, this effort will include scope related to both flow and plate based analytical assays and will incorporate an automation platform that integrates with eLIMS and MES to manage samples from manufacturing in cGMP through final testing results. This effort will extend organizationally to collaborate closely with Process & Analytical Development as well as broader functional partners. The candidate will also be required to build and manage a matrixed team of experienced cell therapy professionals whose responsibility it is to deliver a best-in-class high volume automated analytical platform solution. The scope comprises of defining changes to current analytical methods to enable automation integration to identifying new technologies for all release assays to reduce sample time and increase throughput for a future business state. This individual is required to drive the success and overall sustainability of an analytical automation program by adhering to industry best practices and sound analytical principles to ensure that all methods includes in the automation platform are both comparable to the existing, but meet or exceed the standard of various health authorities
Key Responsibilities
Provide technical and program management to drive an analytical automation platform solution for a best-in-class CAR-T product.
Development of an automation concept through detailed execution planning activities and milestone
Program management leadership to drive the strategic plans/business cases to support selected platform concept, detailed project schedule for implementation, vendor coordination and cross functional collaboration to ensure a seamless introduction in cGMP
Work collaboratively with internal and external partners to identify and drive implementation of industry leading automation solutions
Drives plans for modification of existing analytical methods and ensuring that all methods are able to be integrated into an analytical automation platform
Identifies and drives plans for new analytical technologies that result in paradigm shift in throughput and capacity
Requirements
B.S. required, Ph.D. preferred in technical discipline: engineering, science, or related field
Minimum 12 years of analytical or QC experience, CAR-T experience is highly desirable.
Experience in implementing and managing commercial analytical method improvements and changes
Experience in integrating analytical methods into an automation platform
Candidate must have program management expertise in the life sciences field
Extensive experience in analytical automation technology and vendor offerings specific to commercial analytical platforms, liquid handling & sample handling systems
Extensive knowledge in analytical best practices, industry standards and the latest technologies
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.
#Li-Hybrid
#Li-JK2
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.
Page Limit Reached
Paging is limited to 5 pages for our non registered users. To use this feature you must be Registered and Logged In.
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.