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Car-t Mfg Batch Advocate Mgr
il y a 1 semaine
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.
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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