CAR-T Operations Manager

Our client is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, they are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From the three R&D sites around the world, they apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.  

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. 

As CAR-T Operations Manager, you will oversee cell therapy production and ensure safe and compliant manufacturing operations according to cGMP requirements. You will also oversee the hiring, training & development, and performance management of staff, and ensure the necessary operational tools, processes, systems and people are available to timely accomplish i) clinical readiness, ii) commercial readiness and iii) routine clinical and commercial supply to EU and US.

• 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 fast-responding 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 shut-downs
• Finances: to manage the budget, and seek efficient operating models with positive financial impacts

• Master or Ph.D. in (industrial) Pharmacy, Bio-engineering, BioTechnology, or related field or equivalent experience required
• 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
• 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 cross-functional 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 Hands-on approach
• Self-motivated, 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.
• Dutch and English