CAR T Manager Process Life Cycle Management

Johnson & Johnson Innovative Medicine is recruiting for an Manager Process Life Cycle Management, for the MSAT CAR-T organization, located in Ghent Belgium.

The MSAT CAR-T organization is an organization which provides and supports a high degree of assurance that specific processes will consistently produce and meets its pre-determined specifications by deploying process validation, process system engineering, data architecture and continuous process verification and process investigation.

At the Johnson & Johnson Innovative Medicine, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it. Patients are waiting

The CAR-T Manager Process Life Cycle Management will:

• Partner with local manufacturing, QA/QC, Vein-to-Vein, IT, MAM organizations and global MSAT to define and deploy business compliance strategies on process life cycle management as electronic MBR management, control of change, material & particulates control strategy and knowledge base.
• Will maintain the organizational compliance level and ensure continuous inspection readiness across all MSAT disciplines and functions.
• Takes accountability for process compliance aspects and represent the approach during internal and external Health Authority audits.
• Build and/or maintain strategies in full alignment with global policies to keep compliant documentation processes in place.
• Will manage with the team change control for all process related changes, improvements with local owners and stakeholders.
• Will work in close collaboration with investigation teams, digital & analytic teams, process validation teams to embed process compliance
• Build successful stakeholder relationships by representing MSAT departments in the different functional production areas.
• Leads cross‑functional taskforces to successful completion, driving alignment, removing obstacles, and delivering final objectives on time and to scope.
• Troubleshoot and connect with different stakeholders to make sure non-conformances/CAPA in process execution are resolved in timely manner.
• Communicate issues or delays effectively and proactively to the appropriate business partners in Clinical and Commercial Operations.
• Continuously improve performance of current processes in line with operational business needs.
• Support design of new way of thinking /models and partner closely with global MSAT organization.
• Identify cross-segment opportunities for technology support and best practices
• Drive efficiencies through suitable adoption of new technologies/applications and enhanced approaches to how we operatePerform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.

Required:

• Minimum 4 years of relevant work experience
• Strong working knowledge of current Good Manufacturing Practices (cGMP)
• Good people management and strong technical skills and the ability to work well under pressure
• Experience in the Pharmaceutical, Biotechnology, Cell Therapy, human plasma derived products or related industry is required.
• Prior experience or knowledge in Biologic New Product Development and Manufacturing is required.
• Experience working in the Biotechnology, Pharmaceutical or Medical Device Industry is preferable.
• Strong communication skills, both written and verbal
• Ability to adapt to emerging standard methodologies and industry innovations.
• Experience with financial/budget management is required.

Preferred:

• Communicates effectively with people at all levels, including the ability to understand their priorities, and to earn their respect and trust, along with the willingness to provide them with the best decisions in time-sensitive situations
• Proficiency in English (verbal and written) and strong communication skills are required.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint and Outlook) is required.