Manufacturing Engineer, Technical Support Full Time NEW

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking a Manufacturing Engineer, Technical Support as part of the Technical Operations team based in Raritan, NJ.
Role Overview

The 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

• 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.
• Review batch records updates to ensure alignment with the manufacturing process.
• Be a point of contact with equipment suppliers for timely and continuous support.
• Support the monitoring of the manufacturing process and process execution to identify and support opportunities for improvement and waste reduction.
• Represent the technical support team when interfacing with other departments.
• Perform regular manufacturing operations to collect process health data for the identification of process improvement and waste reduction opportunities.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
• Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses.
• Color Perception both eyes 5 slides out of 8.
• Will be able to make most troubleshooting suggestions, and will work with partners in operations in quality to reach final decisions. For troubleshooting that leads to high process impact, an associate engineer will escalate to our senior team members. Manufacturing engineers will act independently as subject matter experts, especially when working with the Legend investigations team. Manufacturing engineers will independently make procedural updates and perform continuous improvement work.
  

Requirements

• A minimum of a Bachelor’s degree in engineering or related field or equivalent experience required. Advanced degree preferred.
• 3-5 years of operations experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred.
• Fundamental proficiency with the Microsoft office suite.
• Familiarity with Power Apps, Power BI, and Tableau preferred.

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

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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