Associate Manufacturing Engineer

Legend Biotech US; Raritan (NJ); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Performance-based bonus

Equity

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Parental leave

Job summary

Legend Biotech seeks an Associate Manufacturing Engineer, Tech Support, to support development and routine operation of a new CAR‑T manufacturing process. You will be a subject matter expert addressing manufacturing issues and work within the Manufacturing & Supply team in Raritan, NJ.

You will partner with Quality, Compliance and engineering to drive robust problem resolution, support CAPAs and SOPs, and help optimize process health, throughput and waste reduction in a fast-paced biotech

Qualifications

• Bachelor’s degree in engineering or related field; advanced degree preferred.
• 2–3 years of operations in a cGMP biotech/biopharma setting; cell/gene therapy experience preferred.
• Provide technical support to Manufacturing team during operations.
• Able to work shifts to support operations.
• Experience writing SOPs and conducting risk assessments.
• Ability to drive process improvements and participate in audits.
• Collaborate with Manufacturing, Engineering and Quality teams.

Responsibilities

• Partner with Quality, Compliance and experts to resolve process issues while ensuring batch quality.
• Support compliant investigations and CAPAs as subject matter expert.
• Liaise with equipment suppliers for ongoing support.
• Identify opportunities to improve process health and reduce waste.
• Conduct regular manufacturing observations and collect data.
• Serve as primary contact across manufacturing and support teams.

Skills

cGMP operations

biotech industry experience

problem solving

cross-functional collaboration

Education

Bachelor's degree in engineering

Advanced engineering degree preferred

Tools

SOP writing

CAPA systems

Process metrics tracking

Job description

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 & Johnson 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.

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.

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance‑based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a