Legend Biotech · 1 day ago
Investigator (I/II)
Raritan, New Jersey, United States
Full-time
Onsite
Mid, Senior Level
$81K/yr - $107K/yr
5+ years expLegend Biotech is a global biotechnology company focused on developing advanced cell therapies for life-threatening diseases. They are seeking an Investigator I/II to join their Technical Operations team, responsible for providing expertise in cell and gene therapy processes and overseeing manufacturing technologies.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Responsibilities
Lead manufacturing and cross functional investigations from end to end
Ensure thorough root cause analysis, impact assessment, and CAPA/EC determination
Work cross functionally with SME's and Quality to ensure robustness of investigations, as well as accuracy and ensuring compliance
Support and manage change controls and maintain permanent inspection readiness and actively support regulatory inspections
Ensure investigations are processing timely according to site specified requirements
Provide technical expertise in the Technical Operations group, own the process knowledge of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure processes are robust and continuously improving
Ensure seamless flow of knowledge and information across functions, and with other sites when applicable
Provide technical/scientific process support
Provide support and technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations
Support the implementation of manufacturing and process automation strategies through cell therapy manufacturing process design qualification, vendor evaluation, and enterprise system interface engineering support for GMP manufacturing of engineered autologous T cell therapy products
Write and/or review user requirements, functional requirement specifications, qualification protocols, enterprise or system interface, process development reports, and provide technical assessments, rationales, and approval for engineering and process changes to meet regulatory requirements
Work closely with cross-functional teams to design and implement cell therapy processes, manage equipment qualification strategy, and support process validation activities for cell therapy platforms
Work cross-functionally across Technical Operations and interface with external vendors to drive the design and implementation of automation platforms for cell therapy development and manufacturing
Primary role is to support deviation investigation writing
Qualification
Required
BS/BA required in technical discipline: Engineering, science or similar field
A minimum of five (5) years experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred
Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes
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
Support Manufacturing team to troubleshoot and resolve complex scientific/technical problems
Provide technical expertise to drive the implementation of process improvements that would provide reduction in COGs, increase throughput, capacity and quality compliance
Provide technical expertise in automation projects from user requirements, design evaluation, specification review through to testing and implementation in a GMP manufacturing environment
Perform technical feasibility studies related to process improvement and implementation of new manufacturing technologies
Provide SME expertise to perform process characterization of cell therapy automation technologies, including process development, FATs, SATs, and IQ/OQ/PQ testing
Ensure successful manufacturing process comparability and process validation runs by assessing risk, establishing preventative measures, investigating, and troubleshooting equipment and process issues prior to implementation into manufacturing
An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment
Build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless execution of daily production schedules
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options are available to employees in eligible roles
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes vacation days, personal days, sick time, 11 company holidays, and 3 floating holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
2025-12-18
thefly.com
2025-12-09
Company data provided by crunchbase