Senior Principal Scientist, Manufacturing Science and Technology (MSAT)

Deskripsi

Janssen Pharmaceutical Companies of Johnson & Johnson is recruiting for a Senior Principal Scientist, Manufacturing Science and Technology (MSAT), preferably located in Raritan, NJ or Springhouse, PA.

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 Senior 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).
• 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, 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.)

Kualifikasi

Education:

• Vocational, Certificate, Technical, Associates or Bachelor’s degree in a (bio)engineering discipline or related area. A Master’s or PhD degree is a plus.

Experience and Skills: 

• A minimum of ten (10) years of related work experience
• Principal Scientist level will require 6-10 years of experience and a master/PhD degree
• Senior Scientist level will require 4-6 years of experience
• Shown experience in biopharmaceutical manufacturing, experience in cell & gene manufacturing is highly preferred
• Detailed technical knowledge of biopharmaceutical manufacturing site unit operations
• 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.
• Ability to influence and lead peers, superiors, and external partners.
• 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.

Preferred:

• Demonstrated competency and experience with introduction of biological products to manufacturing sites
• Experience with viral vector products and experience with production under (BSL-2) BioSafety conditions.

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.

• The anticipated base pay range for this position is $112,000 to $193,775

• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
• Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. 

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.