Legend Biotech is seeking an Assoc. Manufacturing Engineer, Technical Support (3rd shift) as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Associate Manufacturing Engineer, Tech Support (3rd Shift) will be part of the Technical Support team and be responsible to support the development and routine operation of a new CAR-T manufacturing process. They will be a subject matter expert for the manufacturing process and equipment primarily responsible for providing front line support to address and resolve manufacturing issues.

Key Responsibilities

• Partner closely with Quality, Compliance, and technical experts to drive accelerated, robust, and consistent resolution and escalation of process issues as applicable while ensuring batch quality and adherence to procedures and instructions.
• Support compliant manufacturing investigations and CAPAs, as subject matter experts.
• Be a point of contact with equipment suppliers for timely and continuous support.
• Understand key process indicators of the manufacturing process and process execution and support opportunities for improvement and waste reduction.
• Perform regular manufacturing observations to collect process health data for the identification of process improvement and waste reduction opportunities.
• Act as a primary point of contact across all manufacturing and support organizations. Ability to interact with all levels within the organization.

Requirements

• A minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced degree preferred.
• 2-3 years of operations experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred.
• Provide support and technical expertise to the Manufacturing team in support of ongoing manufacturing operations.
• Ability to accommodate changes in the schedule including working on shift as necessary to support operational needs.
• Support initiatives for process, operational, and quality improvements for manufacturing.
• Maintain processes at a state of audit readiness and support internal and external inspections as required.
• Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes.
• Ability to work with oversight and successfully execute and manage tasks for timely completion, Must respond to shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Support the Manufacturing team to troubleshoot and resolve complex scientific/technical problems.
• Provide technical expertise to support the implementation of process improvements that would provide reduction in COGs, increase throughput, capacity and quality compliance.
• Build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless execution of daily production schedules.
• Candidate must be willing to work both 2nd and 3rd shift hours. This position will start off training on 2nd shift hours. After the initial training period of 4-6 months, the candidate will permanently move to the 3rd shift hours.

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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.