Operations Manager

Legend Biotech US•Raritan, NJ

1d•$127,313 - $167,099•Onsite

About The Position

Legend Biotech is seeking an Operations Manager as part of the Technical Operations team based in Raritan, New Jersey. The 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.

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.
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.
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.

Nice To Haves

Cell/Gene Therapy experience preferred.
Experience with Operational Excellence and/or Lean Manufacturing is an asset.

Responsibilities

Oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.
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.
Be responsible for 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 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

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