Legend Biotech is seeking Operations Supervisor as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The CAR-T Operations Supervisor is an exempt level position working within Technical Operations team, responsible for directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team-based environment, on an assigned production shift schedule.

Key Responsibilities

Lead and supervise multiple units within the CAR-T process operations (i.e. component preparation manufacturing, MFG support operations, Mock cell, and CAR-T process) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.
Lead the daily start of shift operations meetings, the daily wrap up production meetings and assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks.
Work closely with operations personnel on the production floor to provide guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements.
Support manufacturing investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and manage change controls.
Work closely with Operations Manager to help oversee the development of production personnel, provide input on personnel performance.
Build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for operators on the production floor.
Support the development of manufacturing processes, participate in various department projects, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.

Requirements

Bachelor's degree in Science, Engineering or related field or equivalent experience required.
A minimum of 6 years of operations experience within a cGMP environment in the biotech/biopharma industry. Prior experience in manufacturing, quality, or engineering is required. Excellent communication and organizational behaviors skills are required. Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook) is required. Availability to work in a day shift (1st or 2nd shift) is required.
Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell-based products, and cleanroom behaviors.
Must exhibit strong Leadership skills and ability to effectively communicate and influence Operations associate and convey information to Management.
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, while providing clear direction to team members.
Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
Language: English

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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.