Car-t Mfg Batch Advocate Mgr

il y a 1 semaine


Gent, Flandre, Belgique Johnson & Johnson Temps plein
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Manufacturing Batch Advocate


For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.


We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve.

Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

About the role:

Responsibilities & the impact YOU will have**:

  • Represent as the primary manufacturing site "point of contact" for batch disposition of out of specification batches across Commercial, Clinical and Supply Chain teams
  • Manage the collaboration with CAR-T manufacturing and Quality teams to identify early indications a batch may be delayed for any reason
  • Manage clear communication and relationships with Site Quality Head, Technical Operations, Manufacturing and Quality Control regarding batch disposition decisions
  • Represent Manufacturing in a specialized team assembled for discussions with hospitals regarding batches that require delay or release monitoring
  • Immediately assess and prioritize any operational or quality issue for further alert, action or monitoring
  • Upon confirmation of a batch delay, populate a specialized batch monitoring platform
  • Responsibilities span receipt to release from the CAR-T manufacturing facility
  • Provide a specialized level of care to every delayed batch of CAR-T material
  • Collaborate with manufacturing team members to monitor and add influence to expedite resolution of any batch delays
  • Maintain a digital case report for each patient batch requiring delay or release monitoring
  • Support onboarding and training of new country commercial launches for outstanding release process flows
  • Support development and future monitoring of new manufacturing facility workflows for batches that require delay

Qualifications:

Requirements for the role:

Required:

  • Minimum 8 years of relevant work experience
  • Fluency in Dutch
  • Experience in Technical Operations, Quality Control or Manufacturing is required
  • Demonstrated work experience in a CAR-T GMP manufacturing setting
  • Extensive knowledge and/or hands on experience performing tests using and interpreting data from one or more of the following: Automated cell counters, qPCR Methods, Multicolor flow cytometry, ELISA methods for cytokines, Cell Culture, and/or BAC-T sterility
  • Experience in writing, implementing, or reviewing Operations manufacturing SOPs, Work Instructions, Batch Records or Investigations
  • Strong interpersonal skills, positive mentality, and capability of working in a collaborative team environment to effectively relate to all aspects of the manufacturing teams

Preferred:

  • Proficiency in comprehending CAR-T batch data and clearly communicating it to doctors for informed patient care decisions
  • Experience in Quality Investigations within a Manufacturing Operations or Quality Control setting
  • Experience in Quality Management Systems within a Manufacturing setting

Other:

  • Fluency in English required to proficiently read/write/speak to conduct technical discussions
  • Requires availability within 12 hours to connect with sites as needed, locally and globally
  • Requires up to 10% of domestic and/or international travel

This is what awaits YOU at J&J:
Whether you're one of the 1000+ people who work here, or you're considering joining the team, we offer:

  • An opportunity to be part of a global market leader.
  • A dynamic and inspiring working environment.
  • Opportunities to work on ambitious projects and assignments.
  • Possibilities for further personal and professional development/education
  • Excellent Benefits

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