Legend Biotech US
Operations Manager
Raritan, New Jersey, United States
Sponsorship not specifiedDetected 26 days ago
Project ManagementERPPerformance ManagementGMPFDA RegulatoryCRISPRCommunicationCollaborationProblem SolvingCritical ThinkingLean Manufacturing
About the role
- The CAR-T Operations 2 nd Shift Manager is an exempt level position working within Technical Operations.
- This position is an onsite position working Monday to Friday on the 2 nd shift.
Responsibilities
- This individual will create/revise operational procedures, including manufacturing work instructions, master batch records, forms, etc.
- 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.
- 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.
Requirements
- Bachelor's degree in Engineering or related field or equivalent experience required.
- 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.
- 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.
Nice to have
- 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.
Compensation
- 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.
Benefits
- Performance-based bonus and/or equity is available to employees in eligible roles.
- Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one.
- We also provide voluntary commuter benefits, family plannin
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This listing is sourced directly from Legend Biotech US's careers page and normalized into a canonical job model.