Operations Support Specialist, 2nd Shift

Legend Biotech • Raritan, NJ

83d • $46,467 - $60,989

About The Position

Legend Biotech is seeking Operations Support Specialist as part of the Technical Operations team based in Raritan, NJ. 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.

Requirements

• 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.

Responsibilities

• 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.

Benefits

• Medical, dental, and vision insurance
• 401(k)-retirement plan with company match that vest fully on day one
• Equity and stock options available to employees in eligible roles
• Eight weeks of paid parental leave after just three months of employment
• Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating 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
• Commuter benefits
• Family planning and care resources
• Well-being initiatives
• Peer-to-peer recognition programs

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED
• Number of Employees: 1,001-5,000 employees