Legend Biotech US

Operations Supervisor

Raritan, New Jersey, United States

Sponsorship not specifiedDetected 9 days ago

ExcelGMPFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingCritical ThinkingMicrosoft OfficeLean Manufacturing

About the role

Job duties will be performed within a team-based environment, on an assigned production shift schedule.

This individual will 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.
This individual will 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.
This individual's primary responsibility will be to 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.
This individual will support manufacturing investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and manage change controls.
This individual will 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.

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.
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.
Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting.

Performance-based bonus and/or equity is available to employees in eligible roles.
Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.

This individual will need to 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.

This listing is sourced directly from Legend Biotech US's careers page and normalized into a canonical job model.