Associate Manufacturing Engineer

Legend Biotech USA; Raritan (NJ); On-site; USD 70,000 - 95,000; Full time

Job summary

Legend Biotech in Raritan, NJ is seeking an Associate Manufacturing Engineer to join the Manufacturing & Supply team. The role focuses on supporting the development and routine operation of a new CAR-T manufacturing process and serves as a subject matter expert for the manufacturing equipment and processes.

You will provide front-line support to address and resolve manufacturing issues, collaborate with Quality, Compliance, and technical experts, assist with investigations and CAPAs, and work

Qualifications

• Bachelor's degree in engineering or related field; advanced degree preferred.
• 2–3 years of operations experience in a cGMP biotech/biopharma environment.
• Experience with CAR-T manufacturing processes is a plus.
• Ability to work on shift to support operational needs.
• Support SOPs and Quality Risk Assessments for existing and new processes.

Responsibilities

• Partner with Quality, Compliance, and technical experts to resolve process issues while ensuring batch quality.
• Support compliant investigations and CAPAs as subject matter expert.
• Be a primary contact with equipment suppliers for timely support.
• Monitor KPIs and identify opportunities to improve process performance and reduce waste.
• Conduct regular manufacturing observations to collect health data.
• Coordinate with Manufacturing, Engineering and Quality to execute daily production schedules.

Skills

Operations experience

Manufacturing process troubleshooting

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Job description

Legend Biotech is seeking an Associate Manufacturing Engineer as part of the Manufacturing & Supply team based in Raritan, NJ.

Role Overview

The Associate Manufacturing Engineer, Tech Support 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

• This individual will 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.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.

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR‑T), T-cell receptor (TCR‑T), natural killer (NK) cell‑based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting‑edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & J&J to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel;). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

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