Operations Support Specialist

About the Role

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 (Sun-Wed, 1st Shift).

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 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.
• Ability to interact 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 or no prior notice.

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.
• Additional voluntary benefits including 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.
• Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs.

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

Pay

Base Pay Range: $47,861 - $62,819 USD

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Schedule

1st Shift (Sun-Wed)

Ability to accommodate shift work including evenings and weekends as required by the manufacturing process, as well as unplanned overtime on little or no prior notice.

Work Authorization & Employment Eligibility: Applicants must be authorized to work in the United States. The company participates in the E-Verify program.