337818BR
Mar 31, 2022
USA

Job Description

12,000. The number of associates worldwide working together to reimagine medicine!

What You'll Be Doing:

• Responsible for leading early through late stage development of the Novartis Adeno-associated virus (AAV) and Lentivirus gene therapy programs
• Lead and coordinate the drug product asset development team and represent the drug product process discipline in the global CMC project team of assigned programs
• Accountable for managing all drug product development activities including process development, tech transfer, GMP manufacturing technical support, etc.
• Communicate effectively across organizational interfaces i.e. project-management, line functions, senior management, etc.
• Proactively identify scientific, technological and strategic risks, propose creative solutions and communicate key issues to the appropriate management level
• Responsible for high quality drug product process registration documents for health authority submissions and interactions; act as technical expert in audits, inspections, etc.

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you'll bring:

• Advanced degree in relevant scientific field and 5 years relevant large molecule CMC development experience preferred or B.S. with appropriate industry experience
• Previous experience in drug product process development; prior experience in adeno-associated virus and/or lentivirus gene therapy process development preferred
• Strong working knowledge of regulatory CMC expectations with significant experience with IND/BLA submissions
• Strong understanding of the drug development process, in depth knowledge of the strategic and operational aspects of the rare/orphan disease and gene therapy space preferred
• Proven leader that can effectively operate in a cross-functional, matrix environment and successfully manage multiple programs / priorities simultaneously
• Ability to provide strategic guidance to CMC development activities for gene therapy programs and also provide tactical support (i.e. technical expertise, project management, etc) to drive programs forward
• A collaborative attitude, excellent communication skills and problem solving mentality are essential for success
• Up to 10% travel

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

https://www.novartis.com/careers/careers-research/notice-all-applicants…

Global Drug Development
TECHNICAL R & D GDD
USA
Durham, NC
Research & Development
Full Time
Regular
No
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337818BR

Senior Expert, Science & Technology Product Lead

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