The CAR-T QA Project Manager is part of the Quality Leadership Team and Tech Transfer Team. He/She will be responsible to provide QA input and decisions based upon a combination of cGMP knowledge (expertise in advanced therapy medicinal Products regulations) and expertise of cell and gene therapy processes and/or process technologies to establish the appropriate holistic Process Control Strategy. The CAR-T QA Project Manager intended to improve Product Quality, Safety and efficiency and ensure a continuous improvement process.
He/She will act as the QA decision maker for Process and Validation related Subjects together with Operation and Material/Science & Technology. He/She will also partner standards and regulations to maintain and improve existing practices and to implement new innovative manufacturing technologies.
- QA Lead Technical Transfer workstream and QA lead improvement workshops for Validation, cross-contamination prevention etc.
- Be accountable for QA validation strategy design and execution supported on the shopfloor by Operation and MS&T.
- Act as key spokesperson for Health Authorities
- Provide QA expertise in the Technical Operations discussions based upon a combination of intensive GMP knowledge of ATMP¿s, knowledge in aseptic techniques and extensive process knowledge of cell and gene therapy products
- Ensure Process and microbiological control strategy is consistent with cGMP and Janssen requirements
- QA support for transfers out of the Raritan Sister facility.
- Ensure seamless flow of QA knowledge and information across functions, and with other sites when applicable.
- QA review and approval of manufacturing process transfer plans, protocols, and reports.
- Quality assessor and approver of change controls. QA review of process flow diagrams as well as protocol and reports from
- Drive strategy improvements related to process optimizations and reduction of contamination and cross contamination risks
- Master Degree in Bio- Engineering, Science or equivalent technical discipline is required.
- A minimum of 5-10 years within the biotechnological pharmaceutical industry with relevant experience related to manufacturing of Cell and Gene Products is required, preferably in clinical quality, method development, cell banking, cell therapy, or Research & Development.
- Aseptic processing in ISO 5 clean room and biosafety cabinets
- Knowledge and in depth experience of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products (Advanced Therapy and Medicinal Products) as well as knowledge of Good Tissue Practices
- Detailed knowledge of the shop floor manufacturing process.
- Comprehensive knowledge of trending using statistical analysis.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.¿
- Good written and verbal communication skills are required.¿
- The successful candidate must maintain written records of work in the form of notebooks, technical reports and protocols.
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
- Ability to summarize and present results, and experience with team-based collaborations is a must.