Operations Support Specialist
About The Position
Legend Biotech is seeking an Operations Support Specialist to join the Technical Operations team in Raritan, NJ. This role is 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. The CAR-T Operations Support Specialist will perform process unit operations according to standard operating procedures and batch records, while recording production data and information in a clear, concise format. Tasks will be performed on time in a manner consistent with safety policies, quality systems, and cGMP requirements. The specialist will build strong partnerships with Manufacturing, Engineering, and Quality, and work as part of a cross-functional team to complete production tasks. They will also support the development of manufacturing processes and work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations. Job duties routinely require exposure to and handling of biological materials and hazardous chemicals. The role involves establishing key stakeholder relationships with internal and external stakeholders and interacting with all levels within the organization.
Requirements
- Bachelor’s degree in engineering or related field or equivalent experience required.
- A minimum of 0-1 years of operations experience within a cGMP environment in the biotech/biopharma industry.
- 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 of 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 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 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.
Responsibilities
- Perform process unit operations (i.e. cell culture, purification, aseptic processing, 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, 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.
- Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
- Establish key stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan with a company match that vests fully on day one
- Eight (8) weeks of paid parental leave after just three (3) months of employment
- Paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays
- Flexible spending accounts
- Health savings accounts
- Life and AD&D insurance
- Short- and long-term disability coverage
- Legal assistance
- Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
- Voluntary commuter benefits
- Family planning and care resources
- Well-being initiatives
- Peer-to-peer recognition programs
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
501-1,000 employees
