C&q Supervisor

**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.

**Position Overview**

This position will be part of the CAR-T Asset Management team within the Technical Operations group and will be responsible for performing and coordinating Commissioning and Qualification activities within the cGMP Clinical and Commercial Cell Therapy Manufacturing plants in Ghent (Belgium).This individual will be responsible for leading and overseeing day-to-day C&Q activities inclusive of protocol management & execution, management and periodic review of user access and audit trail, periodic system quality review for CAR-T process and lab equipment in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require people management skills, engineering and C&Q experience, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.

**Major Responsibilities**
- Responsible for leading and overseeing day-to-day C&Q activities inclusive of protocol management & execution, management and periodic review of user access and audit trail, periodic system quality review for CAR-T process and lab equipment in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements.
- Manages multiple and complex C&Q projects, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
- Prioritize the use of internal and external resources to most effectively achieve business goals and within budget.
- Develop, lead & coach a team of C&Q Engineers to ensure that all critical production process and lab equipment and systems (assets) in all areas of responsibility comply with all company and/or site Quality & EHS policies and procedures, user requirements, local and federal regulations (e.g., FDA/EU cGMP) and industry standards, guidance and expectations.
- Maintain knowledge of and compliance to all applicable codes and regulations as required.
- Responsible for the planning, execution, tracking and reporting of status and risks/issues associated with C&Q activities for CAR-T production process and lab equipment.
- Coordinates with other departments and/or outside contractors/vendors (if applicable) in case of issues
- Supports in authoring CARA documents (Critical Aspects Risk Assessments), T&TM's (Test & Traceability Matrices), Periodic Qualifications, Project Plans, Master Plans, and PSQR's (Periodic System Quality Reviews).
- Supports in execution of commissioning, qualification, requalification and any associated engineering activities within the plants.
- Supports and/or owns technical investigations detected during C&Q activities.

**Qualifications**:
**Education**
- A minimum of a Master's Degree in Science, Engineering, Bioengineering or equivalent technical discipline is required.

**Experience**

**Capabilities, Knowledge, and Skills**
- Proven people management skills.
- Detailed knowledge and understanding of cGMP, FDA/EU and Industry regulations, standards, guidance and expectations.
- A thorough understanding of Good Engineering Practices (GEP), technical installations, equipment, facilities and (computerized) systems within the Life Science Industry.
- Ability to work independently and successfully, prioritize and manage multiple projects and 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.
- Ability to pay attention to details and follow procedures.
- Strong interpersonal and written/oral communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a requirement.
- Build strong partnerships with Operations, Manufacturing Excellence and Quality to ensure seamless implementation of Engineering and Maintenance projects and/or process improvements.
- Ability to identify/remediate gaps in processes, equipment, facilities and systems.
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