\\n MSAT Principal Scientist

Johnson and Johnson is recruiting for a Manufacturing Science and Technology (MSAT) Principal Scientist, preferably located in Bern, Switzerland or Leiden, The Netherlands.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, 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 are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.

The Principal Scientist we are looking for is responsible for leading the coordination of tech transfer activities and technical services across the platform of the Advanced Therapies. In this role you are charged with running New Product Introductions for life saving drugs and/or drugs with high unmet medical need, such as cell and gene therapy products. You will also be responsible for Life-Cycle Management projects that will drive reliability, innovation and sustainability in our processes and 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 (Senior/Principal) Scientist can work in close collaboration with other roles and must have strong communication skills to influence other functions/levels outside of own group. In this role you will effectively lead global and cross organizational teams to generally attain desired results for all parties. Strong knowledge in cell and gene manufacturing processes is a must. Hands-on experience in both R&D and Manufacturing Operation is highly desirable.

Do you have strong leadership and project management skills, and do you have a passion for biological processes and innovation? If so, then you may be the person we are looking for!
Key Responsibilities:

• Technical and manufacturing integration of new and re-developed processes from R&D into the supply chain (cell/gene therapy products, vaccines, or any other advanced therapy products).
• Supporting the manufacturing site Tech Transfer project team. Ensuring site readiness and launch readiness and performing investigations.
• Ensuring plant readiness and execution from technical transfer into commercial production (e.g., tech transfer implementation, site-based documentation, planning, risk management, budgeting) and launch support.
• Leading projects that will enhance manufacturing output. Your efforts will have a direct impact on patient supply!
• Ensuring product supply from the manufacturing site for which manufacturing performance, cost, and robustness requirements are met.
• Identifying and implementing opportunities for innovation and deploying new technologies, focus on active decrease in COGs, partnering 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.)

Education:

• Master\\\'s degree in a (bio)engineering discipline or related area. A PhD degree is a plus.

Experience and Skills:

Required:

Shown experience in biopharmaceutical manufacturing, experience in (lenti)viral vector manufacturing is highly preferred.

• Principal Scientist level will require 8-10 years of experience.
• Detailed technical knowledge of biopharmaceutical manufacturing site unit operations.
• Ability to influence and lead peers, superiors, and external partners.

Preferred:

• Demonstrated competency and experience with introduction of biological products to manufacturing sites
• Experience with (lenti)viral vector products and experience with 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 (FPX or similar), project planning and structuring.
• Planning and logistics skills, capable of effective integration of deliverables and support execution at the manufacturing site level.
• Good knowledge of GMP, EHS, Q&C, and regulatory requirements.
• Motivated, self-starter able to work independently with demonstrated problem-solving skills
• Excellent stakeholder management skills.

Other:

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

At Johnson & Johnson, we\\\'re on a mission to change the trajectory of health for humanity. That starts by creating the world\\\'s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.\\n \\n \\n \\n \\n \\n

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