Role OverviewThe CAR-T Operations 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.
Key Responsibilities- This individual will oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.
- 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 stakeholder relationships with internal and external stakeholders. Ability to interact with all levels within the organization.
- Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals
- Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/30 (Snellen) or better with corrective lenses.
- Color Perception both eyes 5 slides out of 8
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 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; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
Pay Range (Base Pay):
$127,313-$167,099 USD
Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech. 
