Senior Expert, Science & Technology : GT Drug Substance Product Leader

Senior Expert, Science & Technology

This position will be located at the Durham site and will not have the ability to be located remotely. This position will require 10% travel as defined by the business (domestic and / or international). In this vital role, the Senior Expert, Drug Substance Product Leader will be responsible for leading early through late-stage drug substance development of the Novartis Adeno-associated virus (AAV) and Lentivirus gene therapy programs. This role provides program leadership and supports the advancement of gene therapy programs through drug substance design and generating CMC strategies to meet product and program requirements.

Key Responsibilities

• Lead early through late-stage development of the Novartis Adeno-associated virus (AAV) and Lentivirus gene therapy programs
• Lead and coordinate the drug substance development team and represent the drug substance process discipline in the global CMC project team of assigned programs
• Accountable for managing all drug substance development activities including process development, tech transfer, GMP manufacturing technical support, etc.
• Communicate effectively across organizational interfaces i.e. program-management, technical line functions, regulatory, quality, senior management, etc.
• Proactively identify scientific, technological and strategic risks, propose creative solutions and communicate key risk, issues, and progress to leadership and stakeholders
• Responsible for high quality drug substance process documentation for health authority submissions and interactions; act as technical expert in audits, inspections, etc.
• Develop, mentor and coach other scientific associates; present scientific / technical results internally and contribute to publications, presentations and patents; actively foster knowledge exchange.

Essential Requirements :

Desirable Requirements :

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.