AdresGlobal Product Lead, ATSC MSAT - 2406177701W
Description
Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science – bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world.
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.
POSITION SUMMARY :
Johnson and Johnson Innovative Medicines is recruiting for the Advanced Therapies Manufacturing Science and Technology (MSAT) 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 growing and scaling our high quality cell and gene therapy products? Apply today for this exciting opportunity to be part of the team!
The Head, Global Product Lead – Lenti & Emerging Therapies 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, 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
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 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
Accountable for Continued Process Verification (CPV) and maintaining validated state of products across the network of manufacturing facilities
Serve as senior technical leader representing technical/manufacturing aspects of the product(s) in management 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 enhance productivity, process robustness and efficiency of operations
Create and leverage appropriate data strategies and metrics throughout organization to ensure robust products and processes throughout the lifecycle of the product.
Develop 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.
Champion business cases for changes and improvements related to manufacturing technology implementation or other strategic projects.
Provide 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).
The expected base salary for this role is : $163,000 to $282,900
Qualifications
QUALIFICATIONS, KNOWLEDGE AND SKILLS:
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 and process automation
Ability to lead and influence multidisciplinary, cross-functional teams in an international environment
Project-dependent travelExcellent 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
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 with successful technology transfer and operational readiness for new capital manufacturing assets
Expert knowledge of evolving advanced therapy medicinal products health authority expectations/regulations
Knowledge of data analytics/statistics and process automation
Ability to lead and influence multidisciplinary, cross-functional teams in an international environment including travel to global network of manufacturing sites
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.
Primary Location NA-US-New Jersey-Raritan
Other Locations Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Organization JANSSEN SUPPLY GROUP, LLC (6046)
Relocation Eligible: Yes - Globally
Job Function Manufacturing Engineering
Req ID: 2406177701W
