Director, Advanced Therapies MS&T

Johnson & Johnson is currently seeking a Director, Advanced Therapies MS&T to join our Manufacturing Science and Technology organization located in Raritan, NJ.

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/.

The Director, Advanced Therapies MS&T is accountable for leading the MSAT organization for the site, as well as delivering the product technical roadmap for the Advanced Therapies Supply Chain organization within the manufacturing site. This includes developing robust strategies to maintain the validated state of the cell and gene therapy processes while driving lifecycle management initiatives related to new technologies, automation, technology transfer, etc. This role leads a scientists and engineers who share a common purpose of ensuring the technical and manufacturing requirements of the Advanced Therapies Supply Chain are met throughout the product lifecycle. Serving as the technical lead at the manufacturing site, this leadership position is ultimately accountable for supporting the site’s technical, supply, and compliance related objectives. This position partners with the external manufacturing leaders across quality, supply chain.

ESSENTIAL FUNCTIONS:

• Build and manage a highly engaged world-class site MSAT team providing strategic leadership and direction aligned with the site and Advanced Therapies network.
• Single Point of Contact (SPOC) for Site MSAT needs for CARVYTKI, responsible for managing MSAT team’s contribution towards manufacturing floor support, investigations of major/critical process deviations, impact assessments, process monitoring/continued process verification, MSAT laboratory studies supporting investigations/process improvements, process improvement projects, change management, and data analytics.
• Drives accountability of self and others and creates an environment of innovation and experimentation that facilitates creativity and idea sharing that advances the CARVYKTI platform.
• Proactively promotes compliance, safety, and quality and creates an environment where speaking up and reconciling issues is expected and coaches others to do the same.
• Proactively seeks out, establishes, and sustains a broad set of diverse relationships based on respect within and outside of J&J and holds self and others accountable to do the same.
• Oversee a team serving as the site technical leads for site process technology transfer (in/out) including process qualification/comparability campaigns, process risk assessments, process control strategies and new process training.
• Responsible for oversite, technical support, tracking, and resolution of site investigations, including communication to management.
• Oversee technical support to regulatory filings, regulatory inspections, and health authority questions.
• In collaboration with other functions on site, implement and maintain fit-for-purpose effective systems and business processes to assure compliance to corporate guidelines for Deviation Investigations, Technology Transfer, Capacity scaling, Process Monitoring, Raw Material Qualification, and other relevant areas.
• Planning, execution, and coordination of activities for process monitoring and process data analysis, troubleshooting, facility fit assessments of new processes into the existing manufacturing plant, assessments and writing of technical documents and technical optimization/implementation projects, including experiments conducted both at lab and pilot scale.
• Collaboration in technology transfer projects supporting implementation of new processes in manufacturing operations.
• Creates an environment where others feel comfortable in identifying new ways of working, taking bold action with sense of urgency, and celebrates and rewards those who take calculated risks, learn from mistakes, and make informed decisions.
• Proactively takes action to maximize the professional and personal development of self and others in alignment with business needs.
• Own setting team and individual objectives to meet departmental, business unit, and company objectives, contributing to the wider strategy.
• Identify and conduct performance management activities to ensure behaviors and performance of team meet required expectations, providing training and/or relevant support where needed.

*This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.

AUTONOMY AND COMPLEXITY:

• Lead the platform/product for delivery of site wide/global projects as required.
• Lead troubleshooting of routine manufacturing processes.
• Endlessly curious, seeking to understand the “why” behind complex scientific topics
• Develop, lead and influence implementation of innovative solutions to ensure competitiveness, product quality and process capability improvements
• Can-do mentality, agility & high flexibility able to work with stretched goals and deadlines