MSAT Principal Scientist Full-time

Advanced Therapies Manufacturing Science And Technology (MSAT) Principal Scientist

Johnson and Johnson Innovative Medicines is recruiting for the Advanced Therapies Manufacturing Science and Technology (MSAT) organization! 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. Are you interested in joining a team that is positively impacting patients' lives by growing and scaling our high-quality cell, gene therapy and targeted radioligand therapy products? Apply today for this exciting opportunity to be part of the team! Location Sassenheim (The Netherlands) or Raritan, NJ (USA).

The MSAT Principal Scientist we are looking for is responsible for leading complex, global investigations as well as Life-Cycle Management projects to drive reliability, innovation and sustainability across the Lentiviral Vector production network of the Advanced Therapies Supply Chain at Johnson & Johnson Innovative Medicines. In this position, you will partner with global and local roles across Operations, R&D, Quality, Regulatory Affairs and other Supply Chain functions to ensure processes meet the needs of today and tomorrow. You will lead global cross-organizational teams to effectively attain desired results for all parties.

You must have strong communication skills to influence other functions and (senior) management levels outside your own group. Solid technical understanding in the manufacturing of ATMPs under GMP conditions is a must. Candidates with strong background in biotherapeutics will also be considered. Hands-on experience in both R&D and commercial manufacturing is highly desirable.

Key Responsibilities:

• Lead complex investigations with global cross-functional teams.
• Connect closely with global and site manufacturing and support teams to ensure commercial production and supply demands are met.
• Lead Life-Cyle Management projects that will enhance manufacturing output through optimization and harmonization across Lentiviral vector production sites.
• Identify and implement new technologies; focus on decrease in COGs, partner with R&D and Supply Chain groups to develop and implement strategies to improve the fit for plant and commercialization of new products into the supply chain network.
• Contribute, review and approve product technical and regulatory documents (e.g., protocols, reports, filings, criticality analysis, control strategies, master plans, etc.).

Qualifications:

Required:

• Master's degree in engineering or Equivalent with 8-10 years work experience. PhD degree preferred.
• Strong technical knowledge of ATMP and/or biotherapeutics manufacturing site unit operations (DS and/or DP) under GMP conditions.
• Demonstrated competency and experience leading complex investigations with (global) cross-functional teams.
• Ability to influence and lead peers, senior management, and external partners.

Preferred:

• Experience with (lenti)viral vector products and manufacturing under (BSL-2) BioSafety conditions.
• Experience with manufacturing sterile products.
• Knowledge of manufacturing site systems and procedures (SAP, event and complaint handling, change control, qualification, Process Validation, Continued Process Verification, etc.)
• Demonstrated leadership in providing integration of activities and information across multifunctional groups and matrix teams. Organizing, coordinating teams, and setting up and maintaining communication with stakeholders and wider network organization.
• Project management skills; capable of effective integration of deliverables and support execution at the manufacturing site level.
• Motivated, self-starter able to work independently with demonstrated problem-solving skills.
• Good knowledge of Quality and Compliance, and regulatory requirements including Annex 1.

Other:

• Excellent command of written and spoken English
• 10-25% travel may be required, depending on project needs