Senior Director, Advanced Therapies MSAT

Advanced Therapies Manufacturing Science And Technology (MSAT) Product Lead

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 include : maintaining 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; providing 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 and internal manufacturing sites, new facility construction and start-up including facility design, process qualification / comparability campaigns, process risk assessments, process control strategies and new process training; shaping facility design and representing 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; developing best-in-class team capabilities and overseeing 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; recruiting, retaining, and developing a diverse staff of highly capable technical leaders, scientists, and engineers to create a world-class Advance Therapy MSAT organization; serving as senior technical leader representing technical / manufacturing aspects of the product(s) in senior leadership and governance forums; authoring and / or reviewing technical reports, source documentation, regulatory information requests, filing sections to support product lifecycle advancements and regulatory submissions. Support inspections with regulatory authorities; driving continuous improvement and fostering an operational excellence culture to enhance productivity, process robustness and efficiency of operations; creating and leveraging appropriate data and technology strategies and metrics throughout organization to ensure robust products and processes throughout the lifecycle of the product; accountable for Continued Process Verification (CPV) and maintaining validated state of products across the network of manufacturing facilities including setting the vision and strategy for the data and digital ecosystem and working across a cross-functional team to implement; developing and accountable to implement product technical lifecycle management strategies to drive process / yield improvements, robust process knowledge management and ensure continuing accuracy of regulatory CMC registered detail; championing business cases for changes and improvements related to manufacturing technology implementation or other strategic projects; providing technical leadership to ensure rapid resolution of technical issues impacting supply through robust investigations, leveraging root cause analysis (RCA) tools and developing appropriate Corrective and Preventative Actions (CAPA); authoring and / or reviewing technical reports, source documentation, regulatory information requests, regulatory filings. Support inspections with regulatory authorities.

Qualifications, knowledge and skills include : University / Bachelors Degree in Science / Engineering or Equivalent with 15+ Years Biotech / Pharmaceutical experience or Masters / PhD degree in Engineering, with 10+ years Biotech / Pharmaceutical experience or equivalent industry experience; hands-on experience in Manufacturing Operations and / or R&D in a biopharmaceutical manufacturing setting (ie. cell / gene therapy products, vaccines, or any other advanced therapy products); experience leading technology transfer activities and technical services for cell / gene therapies; excellent technical skills and problem-solving skills; knowledgeable in manufacturing sciences, cGMP compliance, change management methodology and advanced therapies product regulatory and validation requirements; knowledge of data analytics / statistics, process automation, lean / operational excellence tools; ability to lead and influence multidisciplinary, cross-functional teams in an international environment; project-dependent travel; excellent judgment. able to prioritize and decide appropriate courses of actions; effective at implementing decisions, troubleshooting and problem-solving skills in a fast-paced environment. Expert knowledge in manufacturing sciences and operations support, technology transfer, process comparability process monitoring, change management, cGMP compliance, and advanced therapies (ie. cell / gene therapy products, vaccines) product regulatory and validation requirements.