Director / Sr. Director, Cell Process Development
- East Hanover, NJ
1 purpose - Reimagining Medicine!
The Director/Senior Director, Cell Process Development will serve as a strategic partner and advisor for the technical staff within the Cell & Gene Therapy - Technical Development organization. This senior role will provide key input to shape both early- and late-stage development strategies for our CAR-T therapies by collaborating closely across a number of functions within the organization including but not restricted to Research/Discovery, Program Management, Clinical Manufacturing, Quality, and Regulatory-CMC! The ideal candidate will have broad expertise in CMC development and compliance, complemented by deep technical expertise in cell processing technology. This role will report to the Global Head of Technical Development for CAR-T programs and will participate and/or lead several cross-functional committees.
Your responsibilities include, but are not limited to:
• Experienced leader with deep technical insights that drives key initiatives including trouble-shooting Manufacturing challenges.
• Establish metrics and tracking mechanisms to trend processes in terms of performance with clear traceability to source records.
• Evaluate and implement automated cell processing technologies with the potential to integrate with automated analytical technologies while drafting the appropriate accompanying documentation for training and consistency.
• Active participation with potential to lead cross-functional committees with broad scope.
• Establishes forums for information sharing to enable development decision making.
• Develops and maintains strong, internal partnerships with cross-functional colleagues.
• Authors and reviews technical documents including summary reports and procedures to hand over to internal and/or external partners including source documents for regulatory submissions.
• Delivers high impact, technical findings and concepts to senior leaders within the organization.
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
What you'll bring to the role:
• Education: Ph.D. in Bioengineering or related scientific discipline.
• Minimum 10 years of in-depth cell process development experience with a consistent track record of leading technical teams and projects preferred.
• Deep expertise in cGMP requirements and active engagement in the evolving field of regulatory science.
• Experience interacting with health authorities (from correspondence and Requests for Information to audits and inspections).
• Proven ability to partner with diverse line functions to develop strategic initiatives.
• Excellent organizational and communication skills.
• Strong presentation skills and scientific writing skills with extensive experience authoring technical documents.
• Position will be filled at level commensurate with experience.
Why consider Novartis?
799 million. That's how many lives our products touched in 2019. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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