Operations Support Specialist at Legend Biotech US in Raritan, New Jersey, United States

Job description

• 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.

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

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.

Skills

Required

• Communication
• Attention to detail
• Ability to work independently
• Prioritization
• Teamwork
• cGMP
• FDA regulations
• Cell culture
• Purification
• Aseptic processing
• Cryopreservation
• BSL-2

Benefits

• Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include 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. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
• Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.
• The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.
• Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.
• $47,861 - $62,819 USD