Car-t Operations Manager - Gent, België - Legend Biotech EU
Beschrijving
Company Information
Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Role Overview
You will be responsible for the
start-up, readiness
and next
management of routine manufacturing operations of CAR-T
manufacturing plant to supply both Europe and US.
You will be in charge of the operations and timely CAR-T manufacturing for clinical trials and commercial use within a sterile cGMP environment.
You will be responsible for compliance with quality and safety standards, within the allocated budget.You also act as a leader for continuous improvement, and key contact with Training, Quality Operations, Supply Chain, MS&T, Production Maintenance.
You will report to the Head of Manufacturing, Europe.Major Responsibilities
As CAR-T Operations Manager, you will oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements.
You will build strong partnerships with:
- MS&T: to support Tech Transfer, Process Optimizations, Qualifications and Validations
- Quality: to build and manage a fully compliant cGMP plant, and act as key contact of regulatory and health authorities' audits or inspections
- Planning: to build together an agile, efficient and fastresponding workflow and planning tool
- HR: to support recruiting, onboarding, managing, and developing a strong, agile, flexible manufacturing team with a 'can do attitude' mindset
- Supply Chain: to support an agile material process flow
- Production Maintenance: to ensure timely equipment qualification & maintenance and to define the strategy ensuring business continuity during clean room shutdowns
- Finances: to manage the budget, and seek efficient operating models with positive financial impacts
Education
Master or Ph.
D. in (industrial) Pharmacy, Bio-engineering, BioTechnology, or related field or equivalent experience required
Experience
- Minimum of 10 years of directly related GMP manufacturing experience in pharmaceutical or biotech industry.
- At least 5 years of aseptic GMP manufacturing experience
- Excellent track record of managing diverse operational teams is a must
- Prior experience in manufacturing, quality, or engineering is required
Capabilities, Knowledge, and skills
- An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
- Inspiring leader, with strong, demonstrated interpersonal skills.
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate crossfunctional issues and balance competing priorities effectively.
- Highly developed organizational skills. 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, pragmatic and positive critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
- Can do attitude, Right first time and Handson approach
- Selfmotivated, enthusiastic personality, team player
- 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.
Language(s):
Dutch and English
LI-AG1
Legend Biotech maintains a drug-free workplace.
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