C&Q Supervisor

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

• A minimum of 3 years relevant C&Q and people oriented work experience within a cGMP environment. It is preferable that the candidate has experience working in an Aseptic manufacturing facility.

Capabilities, Knowledge, and 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.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Strong interpersonal and written/oral communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Proficient in applying process excellence and QRM tools and methodologies.
• 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.
• Experience in authoring and executing documentation including, but not limited to: (electronic) Batch Records, SOPs, Work Instructions, C&Q documents.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
• Experience with SAP, Change Control system and DMS is preferred.

Language(s)

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.

Legend Biotech maintains a drug-free workplace.

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Who are we?

Legend Biotech BV (incorporated under the laws of Belgium with registered offices at 9050 Gent, Gaston Crommenlaan 8, with enterprise number 0769.992.730) is part of the Legend Biotech group, a global clinical-stage biotechnology company developing and manufacturing innovative cellular therapies, dedicated to quality and excellence and committed to improving the lives of patients worldwide.

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Unless at the end of the application process we enter into a contractual relationship with you, your personal data will be kept for the duration of no more than 735 days after the termination of the job application process.

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You may exercise any of the rights indicated below at your discretion, to the extent permitted by applicable law.

Right to withdraw consent. If the processing is based on consent only, you shall at all times have the right to withdraw this consent, without such withdrawal of the consent affecting the legality of the processing that took place before the withdrawal.

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Right to restriction of Processing. You have the right to obtain from us the restriction on processing of your personal data if (a) the accuracy of your personal data is disputed by you.

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If with respect to our collection and processing activities regarding your personal data you have questions, inquiries or complaints or if you wish to exercise the rights granted to you by the applicable law, please contact us via the following means:

LEGEND BIOTECH BV

9050 Gent

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