Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking an Operations Manager (2nd Shift) as part of the Technical Operations team based in Raritan, New Jersey.
Role Overview
The CAR-T Operations 2nd Shift Manager is an exempt level position working within Technical Operations. This individual will be responsible for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. This position is an onsite position working Monday to Friday on the 2nd shift.
Key Responsibilities
- This individual will oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.
- This individual will be a site management resources and point of contact for all 2nd shift employees.
- This individual will be the primary point of contact for 2nd shift Technical Operation’s supervisors of their respective areas of oversite.
- This individual will take direction and guidance from their Associate Director and or Senior Managers of the process areas
- This individual will also oversee the hiring, development, and performance management of staff, and assign personnel to execute daily production schedules.
- This individual will create/revise operational procedures, including manufacturing work instructions, master batch records, forms, etc.
- This individual will be responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics.
- This individual will support manufacturing investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.
- This individual will need to build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production schedules.
- This individual will also lead facility operating review meetings and own various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.
- Establish key relationships with internal and external stakeholders. 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 5 years of operations experience within a cGMP environment in the biotech/biopharma industry with a minimum of 3 years supervisory experience. Cell/Gene Therapy experience preferred.
- 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.
- Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
- Clear and succinct verbal and written communication skills.
- Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
- Basic project management skills, responsiveness to issues, and demonstrated passion for creating new medicines
- Experience with Operational Excellence and/or Lean Manufacturing is an asset.
- Ability to accommodate shift work including daily overtime and weekends, as required by the manufacturing process.
- Ability to accommodate unplanned overtime on little to no prior notice.
- 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.
- Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
- GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.
- Technology & Automation: Familiarity with modern manufacturing systems (MES, ERP, etc.) and digital transformation initiatives.
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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; 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.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.
Skills Required
- Bachelor's degree in Engineering or related field or equivalent experience
- Minimum 5 years operations experience in a cGMP biotech/biopharma environment
- Minimum 3 years supervisory experience
- Ability to work onsite 2nd shift and accommodate daily/unplanned overtime and weekends
- Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing (GMP compliance)
- Familiarity with modern manufacturing systems (MES, ERP) and digital transformation initiatives
- Ability to build strong cross-functional and external collaborator partnerships in a matrixed environment
- Strong verbal and written communication skills
- Strong analytical, problem solving, and critical thinking skills; ability to lead change
- Basic project management skills and responsiveness to issues
- Experience with Operational Excellence and/or Lean Manufacturing
- Cell/Gene Therapy experience
