Operations Manager
Legend Biotech US•Raritan, NJ
•$127,313 - $167,099•Onsite
About The Position
Legend Biotech is seeking an Operations Manager (2nd Shift) as part of the Technical Operations team based in Raritan, New Jersey. 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.
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.
- Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.
- Familiarity with modern manufacturing systems (MES, ERP, etc.) and digital transformation initiatives.
Nice To Haves
- Cell/Gene Therapy experience
Responsibilities
- Oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.
- Serve as a site management resource and point of contact for all 2nd shift employees.
- Act as the primary point of contact for 2nd shift Technical Operation’s supervisors of their respective areas of oversight.
- Take direction and guidance from their Associate Director and/or Senior Managers of the process areas.
- Oversee the hiring, development, and performance management of staff, and assign personnel to execute daily production schedules.
- Create/revise operational procedures, including manufacturing work instructions, master batch records, forms, etc.
- Oversee multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics.
- Support manufacturing investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.
- Build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production schedules.
- 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.
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
- 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
- Voluntary commuter benefits
- Family planning and care resources
- Well-being initiatives
- Peer-to-peer recognition programs
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What This Job Offers
Job Type
Full-time
Career Level
Manager
