SUMMARY

Job Description Summary
Internal Title: 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).

Hybrid

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.

ESSENTIAL REQUIREMENTS:

• Bachelors’ degree in relevant scientific field and 5 years of relevant industry experience
• 3+ years’ relevant large molecule CMC development experience
• Strong working knowledge of regulatory CMC expectations with significant experience with IND/BLA submissions
• Strong understanding of the drug development process
• 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
• Potential of up to 10% domestic travel

DESIRABLE REQUIREMENTS:

• Previous experience in drug substance development; prior experience in adeno-associated virus and/or lentivirus gene therapy process development preferred
• In depth knowledge of the strategic and operational aspects of the rare/orphan disease and gene therapy space preferred
• Advanced degree in relevant scientific field

NOVARTIS COMPENSATION AND BENEFIT SUMMARY

The salary for this position is expected to range between $114,100 and $211,900 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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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.