Msat Principal Scientist

Johnson and Johnson is recruiting for a
Manufacturing Science and Technology (MSAT)
Principal Scientist, either located in
Bern, Zwitzerland or located in
Leiden, The Netherlands with the ability to travel to Bern up to 50% of the time.

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 redeveloped processes from R&D into the supply chain (cell/gene therapy products, vaccines, or any other advanced therapy products).
• Leading the manufacturing site Tech Transfer project team and being the manufacturing site representative on the R&D team and the Value Chain Team. Ensuring site readiness and launch readiness.
• Single point of contact for Janssen Advanced Therapies Supply Chain (ATSC) plant readiness and execution from technical transfer into commercial production (e.g., tech transfer implementation, sitebased 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.)

Qualifications:

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 810 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 (BSL2) 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, selfstarter able to work independently with demonstrated problemsolving skills
• Excellent stakeholder management skills.

Other:

• Fluent in written and spoken English
• 1025% travel may be required, depending on project needs if located in Bern, 2550% travel may be required, depending on project needs if located in Leiden

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 or

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