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 Principal Scientist we are looking for is responsible for leading complex, global investigations and improvement and harmonization projects across the lentiviral vector production network of the Advanced Therapies Supply Chain for life saving drugs and/or drugs with high unmet medical need. You will also be responsible for Life-Cycle Management projects that will drive reliability, innovation and sustainability in our processes and manufacturing plants, both internally and externally. In this role, you will partner with R& D, Quality, and Regulatory to ensure processes meet the needs of today and tomorrow. The Principal Scientist will work in close collaboration with other global and local roles and must have strong communication skills to influence other functions and management levels outside of their own group. In this role you will effectively lead global and cross-organizational teams to generally attain desired results for all parties. Solid technical understanding in cell and gene therapy manufacturing processes under GMP conditions is a must. Hands-on experience in both R& D and Manufacturing Operation is highly desirable.

Key Responsibilities:

• Lead complex and global investigations with cross-functional teams.
• Connect closely with site manufacturing and support teams to ensure manufacturing and supply demands are met.
• Lead projects that will enhance manufacturing output through optimization and harmonization across production sites. Your efforts will have a direct impact on patient supply!
• Identify and implement new technologies; focus on decrease in COGs, partner with R& D and JSC groups to develop and implement strategies to improve the fit for plant and commercialization of new products into the supply chain.
• Contribution, review and approval of the 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.
• Detailed technical knowledge of biopharmaceutical manufacturing site unit operations (DS and/or DP) under GMP conditions.
• Demonstrated competency and experience leading complex investigations with cross-functional teams.
• Ability to influence and lead peers, superiors, and external partners.

Preferred:

• Experience with (lenti)viral vector products and production under (BSL-2) BioSafety conditions.
• 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.

Other:

• Fluent in written and spoken English
• 10-25% travel may be required, depending on project needs