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Technical Operations Support Associate
2 months ago
Legend Biotech is a pioneering global biotechnology firm committed to addressing and ultimately curing life-threatening illnesses. With our headquarters in Somerset, New Jersey, we are at the forefront of developing cutting-edge cell therapies utilizing a variety of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
In 2017, Legend Biotech entered into a strategic global collaboration with Janssen, a subsidiary of Johnson & Johnson, to co-develop and commercialize ciltacabtagene autolecuel (cilta-cel). This partnership aims to leverage the strengths and expertise of both organizations to enhance the potential of immunotherapy in treating multiple myeloma.
Legend Biotech is currently looking for an Operations Support Specialist to join the Technical Operations team.
Position Summary
The Operations Support Specialist will be an integral part of the Technical Operations team, responsible for the production of personalized cell therapies to meet both clinical and commercial needs within a sterile cGMP environment. The role involves working within a team based on a designated production shift schedule.
Key Responsibilities
- Assist in process operations by executing specific support tasks and real-time floor service activities (such as kitting, kit cleaning, inventory management, data entry, sample management, and aseptic behavior for equipment cleaning and cryopreservation) in accordance with standard operating procedures and batch records, while accurately documenting production data.
- Complete tasks punctually while adhering to safety policies, quality systems, and cGMP standards.
- Foster strong collaborations with Manufacturing, Warehouse, Engineering, and Quality teams, working cohesively to fulfill production requirements as per the shift schedule.
- Contribute to the enhancement of manufacturing processes and collaborate with colleagues to drive continuous improvements and efficiencies within cell therapy Technical Operations.
- High School Diploma with relevant experience required; or a Certificate or Associate's degree in a scientific or health services field preferred; Bachelor's degree in a scientific or health services field is also preferred.
- A minimum of 0-1 years of experience in Operations within a cGMP environment in the biotech/biopharma sector.
- Proficient in computer skills to navigate specialized software and databases.
- Ability to build effective partnerships and collaborate with external stakeholders to advance projects in a matrixed environment.
- Capability to work independently, prioritize, and manage multiple tasks simultaneously while balancing competing priorities effectively.
- Strong verbal and written communication skills with a keen attention to detail and adherence to procedures.
- Familiarity with cGMP regulations and FDA guidelines related to the manufacturing of cell-based products.
- Physical ability to lift a minimum of 50 lbs. and maintain standing for extended periods.
- Vision and hearing capabilities sufficient to operate in a job environment requiring physical dexterity for computer use and documentation.
- Ability to handle human-derived materials in a BSL-2 cleanroom setting.
- Willingness to accommodate shift work, including evenings and weekends, as dictated by the manufacturing process.
- Flexibility to manage unplanned overtime with little to no prior notice.
Legend Biotech is an equal opportunity/affirmative action employer dedicated to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. We ensure equal employment opportunity without discrimination or harassment based on any characteristic protected by law.
Legend Biotech maintains a drug-free workplace.
