Operations Support Specialist

legendcareers; Raritan (NJ); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company-m

Eight weeks paid parental leave

Paid time off

Job summary

Legend Biotech is seeking an Operations Support Specialist 1st Shift (Sun-Wed) in Raritan, NJ, to join the Technical Operations team. You will perform cellular processing steps, record production data, and collaborate across Manufacturing, Engineering, and Quality to ensure compliant, on-time production of cell therapy products.

The role requires a Bachelor's in engineering or related field with 0-1 years in a cGMP biotech setting, plus the ability to lift 50 lbs and work evenings/weekends as

Qualifications

• Bachelor's degree in engineering or related field or equivalent experience.
• 0-1 years of operations experience within a cGMP biotech/biopharma environment.
• Ability to work independently and manage multiple tasks in a matrixed environment.
• Clear and succinct verbal and written communication with attention to detail.
• 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 long periods.
• Ability to accommodate shift work including evenings and weekends.

Responsibilities

• Perform process unit operations (cell culture, purification, aseptic processing, and cryopreservation) per SOPs and batch records.
• Record production data clearly and concisely.
• Work with Manufacturing, Engineering, and Quality in a cross-functional team to complete shift tasks.
• Support development of manufacturing processes and drive continuous improvements in Technical Operations.
• Handle biological materials and hazardous chemicals routinely in a cGMP environment.
• Interact with all levels within the organization.

Skills

Attention to detail

Verbal and written communication

Cross-functional collaboration

Education

Bachelor's degree in engineering or related field

Job description

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking an Operations Support Specialist 1st Shift (Sun-Wed) as part of the Technical Operations team based in Raritan, NJ.

Role Overview

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.

Key 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.
• 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 to no prior notice.

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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.

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; demonstrati