Associate Director, MSAT (Advanced Therapies)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Process Engineering

Job Category:

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for an Associate Director, MSAT (Advanced Therapies) based in Raritan, NJ, Spring House, PA or Malvern, PA.

Purpose:

Johnson and Johnson Innovative Medicines is recruiting for the Manufacturing Science and Technology 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 ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the team!

The Associate Director serves as part of the Global Technical Team, reporting to the Director, MSAT LCM within the Advanced Therapies Manufacturing Science and Technology Organization.  They are the single point of contact at the manufacturing site for the technical team, responsible for driving implementation of key initiatives related to the product technical roadmap and lifecycle management plan for the Advanced Therapies Supply Chain portfolio of products.  Example focus areas include projects that will drive reliability, innovation and sustainability in our processes and plants, both internally and externally. Cross-functional partnership with R&D, Quality, and Regulatory will be required to ensure processes meet the needs of today and tomorrow.

You will be responsible for:

• Partner cross-functionally across the MSAT organization and site operations, owning the coordination of all technical activities at the contract manufacturer.

• Provide technical leadership and strategic direction for manufacturing processes, ensuring scalability and robustness.

• Lead the development of technical, quality, & compliance risk assessments/mitigation strategies and possible business continuity plans

• Proactively monitor technical process and product performance to detect trends and develop mitigation plans.

• Collaborate closely with R&D, Quality, Regulatory, and Manufacturing teams to identify and resolve technical challenges.

• Reviews technical product & process risk profiles and criticality analysis

• Develop and implement manufacturing process improvements, validation strategies, and troubleshooting plans.

• Support regulatory filings by preparing technical documentation and responding to agency inquiries.

• Drive innovation by evaluating new manufacturing technologies, equipment, and methodologies.

• Ensure compliance with cGMP regulations, safety standards, and corporate policies.

• Interface with the CMO leadership to align on project timelines, budgets, and quality expectations.

• Contribute to the development of the long-term supply strategy including scenario development and E2E impact analysis

• Collaborate with R&D, site functions and finance to identify COGS improvement opportunities (COGS optimization process)

• Lead improvement/innovation opportunities, to build project business cases and to prioritize projects (product related)

• Democratize process information across sites<