Operations Support Specialist

The Operations Support Specialist will be part of the Technical Operations team responsible for the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a team based on an assigned production shift schedule.

Shift Schedule: Sunday - Wednesday 2nd Shift (1PM-12:30AM), * Support process operations by performing support specific and real-time floor service tasks (i.e., kitting and kit cleaning, inventory management and data entry, sample management and data entry, aseptic behavior for cleaning of equipment, and cryopreservation) according to standard operating procedures and batch records, while recording production data and information in a clear, concise format.

• Perform tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Build strong partnerships with Manufacturing, Warehouse, Engineering, and Quality, and work as part of a cross-functional team to complete production tasks required by shift schedule.
• Support the development of manufacturing processes and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.

• H.S. Diploma with relevant experience required; or Certificate or Associate's degree in a scientific or health services field preferred, Bachelor's degree in a scientific or health services field preferred.
• A minimum of 0-1 years of Operations experience within a cGMP environment in the biotech/biopharma industry.
• Proficient computer skills to be able to navigate specialized software and databases.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
• Knowledge of cGMP regulations and FDA guidance related to manufacturing cell-based products.
• Ability to lift a minimum of 50 lbs. and stand for a long period of time.
• Sufficient vision and hearing capability to work in a job environment with physical dexterity sufficient to use computers and document production records.
• Ability to handle human derived materials in BSL-2 cleanroom facility.
• Physical dexterity is sufficient to use computers and documentation.
• Ability to accommodate shift work including evenings and weekends as required by the manufacturing process.
• Ability to accommodate unplanned overtime on little to no prior notice.

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):

$41,467 - $60,989 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 Operations Support Specialist, Sun-Wed 2nd Shift 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.