Operations Support Specialist
Legend Biotech US•Raritan, NJ
•$47,861 - $62,819•Onsite
About The Position
Legend Biotech is seeking an Operations Support Specialist as part of the Manufacturing & Supply team based in Raritan, NJ. The CAR-T 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.
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.
Benefits
- Medical, dental, and 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 and 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
