Investigator Associate

**Company Information**

Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.

**Role Overview**

The Investigator Associate will be part of the Technical Operation team and will be responsible to provide specialist knowledge and expertise of cell and gene therapy processes and/or process technologies. They will also oversee processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.

**Major Responsibilities**:

- This individual will be providing 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.
- Ensures seamless flow of knowledge and information across functions, and with other sites when applicable.
- Provides technical/scientific process support.
- Support manufacturing investigations, support and manage change controls and maintain permanent inspection
readiness and actively support regulatory inspections.
- This individual will also 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.

**Qualification**

**Education**:
A minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced degree preferred.

**Experience**:
5 years of operations experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred

**Capabilities, Knowledge, and skills**:

- Provide support and technical expertise to the Manufacturing team in support of ongoing technical
transfer and manufacturing operations.
- 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.
- 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.
- 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.

**Language(s)**:
English

LI-AG1

Legend Biotech maintains a drug-free workplace.