Senior Director, Advanced Therapies MSAT

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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Job Description:

Johnson and Johnson Innovative Medicines is recruiting for the Advanced Therapies Manufacturing Science and Technology (MSAT) organization to be located in Springhouse PA or Horsham PA! 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 and gene therapy products Apply today for this exciting opportunity to be part of the team!

POSITION SUMMARY:

Johnson & Johnson Innovative Medicines is seeking a visionary leader to drive the future of advanced therapies manufacturing. As the Global MSAT Advanced Therapies Product Lead you will shape and operationalize new advanced therapy manufacturing modalities across a global network enabling life-changing cell and gene therapies to reach patients worldwide. This role is pivotal in leading enterprise initiatives including next-generation manufacturing and automation and building a culture of innovation and operational excellence.

You will be accountable for the strategic direction technology transfer leadership and execution of complex facility construction start-ups (>$1B capital). Your leadership will directly impact patient outcomes and the companys mission to create a world without disease.

ESSENTIAL FUNCTIONS:

Strategic Leadership & Vision:

• Shape and communicate a compelling vision for advanced therapies manufacturing aligning global teams to deliver transformative patient outcomes.
• Influence and inspire cross-functional multidisciplinary teams in an international environment.

Automation & Digital Transformation:

• Lead the implementation of smart manufacturing technologies & automation and data-driven process monitoring.
• Develop and execute a robust data and digital strategy for process verification and lifecycle management.

Technical Excellence & Regulatory Expertise:

• Accountability for technology transfer process qualification and comparability for advanced therapy products.
• Ensure compliance with global regulatory requirements (FDA EMA etc.) authoring and reviewing technical reports and regulatory submissions.
• Maintain validated state of products and drive continuous improvement in process robustness and efficiency.

Facility Design & Operational Readiness:

• Shape facility design for manufacturability automation and lean operations.
• Represent MSAT in matrix leadership teams for facility construction and start-up programs.

Team Development & Culture:

• Recruit retain and develop a diverse world-class team of technical leaders scientists and engineers.
• Foster a culture of innovation inclusion and continuous learning.

Change Management & Problem Solving:

• Champion business cases for technology implementation and strategic projects.
• Lead rapid resolution of technical issues using root cause analysis and CAPA methodologies.

Lifecycle Management:

• Develop and implement product technical lifecycle strategies to drive process/yield improvements and robust knowledge management.

QUALIFICATIONS KNOWLEDGE AND SKILLS

• University/Bachelors Degree in Science/Engineering or equivalent with 15 years in Biotech/Pharmaceutical or Masters/PhD with 10 years relevant experience.
• Proven leadership in new facility design construction and operational readiness for advanced therapies or innovative product technologies.
• Deep expertise in automation systems data integration and digital transformation in biopharma manufacturing.
• Hands-on experience in manufacturing operations and/or R&D for cell/gene therapy products vaccines or other advanced therapies.
• Demonstrated success in technology transfer process qualification and regulatory submissions for global markets.
• Advanced knowledge of cGMP compliance change management and validation requirements.
• Strong data analytics/statistics skills and deep experience with lean/operational excellence tools.
• Exceptional judgment prioritization and decision-making abilities in fast-paced environments.
• Effective communicator and influencer across all levels of the organization.
• Project-dependent travel required.

The anticipated base range for this role is: $ 173000- $299000.

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.