Manufacturing Engineer, Technical Support

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., * 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.

• 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.

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 paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$81,273 - $106,669 USD

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

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., Legend Biotech was founded as an early-stage cell therapy company in 2014. The company was the brainchild of visionary scientists who recognized that antibody-based therapeutics could potentially treat disease and possessed the backgrounds in immunology and gene editing to take the leap. For two years, Legend Biotech, then known as the "Legend Project," operated in a room the size of a freight elevator, with the goal of creating a cell therapy for multiple myeloma, a hematological cancer that often relapses and can become refractory. The team produced nanobodies for single-domain antibody drugs and ultimately extended the half-life of the nanobodies with proprietary technologies. In 2015, Legend's scientists focused on research for chimeric antigen-receptor T-cells (CAR-T) targeting the BCMA protein, making the biotech one of the first companies in the world to engineer CAR-T cells for the BCMA protein. In 2016, investigator-initiated trials began in China. In 2017, data from the trials were presented at the American Society for Clinical Oncology (ASCO), which led to a partnership with biopharmaceutical company Janssen Biotech, Inc. to co-develop the anti-BCMA CAR-T, ciltacabtagene autoleucel (cilta-cel). Applications seeking approval of cilta-cel for the treatment of patients with RRMM are currently under regulatory review by several health authorities around the world. CARVYKTI (ciltacabtagene autoleucel) was approved by the U.S. Food and Drug Administration in February 2022 and received conditional marketing approval from the European Medicines Agency in May 2022. Today Legend Biotech is a global, commercial-stage company driven by a passion for patients. We continue to build our pipeline of cell therapy platforms, which includes CAR-T, CAR-NK, CAR-γδ T and non-gene-editing CAR technologies. Our goal is to bring hope and opportunity to patients and their families by continuing to explore unique technologies.