Senior Director, Advanced Therapies MSAT

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:

Horsham, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America

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!

The MSAT Product Lead is accountable to enable and operationalize new advanced therapy manufacturing modalities across a network of global manufacturing facilities.  This role leads the MSAT function for complex manufacturing facility construction start-ups (>$1B in capital) while simultaneously leading across operational network of internal manufacturing sites and CMOs.  This is a multi-country, enterprise leadership driving enterprise initiatives including next generation manufacturing and automation of cell therapies, shaping the strategic direction of advanced therapies, and creating a strong leadership presence across hundreds of team members.

ESSENTIAL FUNCTIONS:

·        Maintain a robust MSAT support network for all commercial activities related to life cycle management, new technologies, automation, change management, comparability and technology transfers across advanced therapies technology platforms. 

·        Provide technical and strategic leadership to a rapidly expanding global manufacturing network for best in class advanced therapy products and best in class manufacturing

·        Accountable for the products’ technology transfer of advanced therapy products to CMOs, internal manufacturing sites, new facility construction & start-up including facility design, process qualification/comparability campaigns, process risk assessments, process control strategies and new process training.  

·        Shape facility design and represent MSAT on matrix leadership teams for internal and or CMO facility design and construction programs with an eye towards lean, manufacturability, automation and process robustness

·        Develop best-in-class team capabilities and oversee MSAT team's contribution towards manufacturing floor support, investigations of major/critical process deviations, impact assessments, process monitoring/continued process verification, design of laboratory studies supporting investigations/process improvements, process improvement projects across a network of manufacturing facilities

·        Recruit, retain, and develop a diverse staff of highly capable technical leaders, scientists, and engineers to create a world-class Advance Therapy MSAT organization

·        Serve as senior technical leader representing technical/manufacturing aspects of the product(s) in senior leadership and governance forums

·        Author and/or review technical reports, source documentation, regulatory information requests, filing sections to support product lifecycle advancements and regulatory submissions.  Support inspections with regulatory authorities

·        Drive continuous improvement and foster an operational excellence culture to enhan