Gene Therapy Drug Substance Product Leader Position Available In Durham, North Carolina

Internal job title: Senior Expert, Science & TechnologyIn 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.

This position will be located at Durham, NC and will not have the ability to be located remotely. This position will require up to 10% travel as defined by the business (domestic and/ or international).#LI-HybridKey ResponsibilitiesLead early through late-stage development of the Novartis Adeno-associated virus (AAV) and Lentivirus gene therapy programsLead 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 stakeholdersResponsible 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.

Role Requirements:

Bachelors’ degree in relevant scientific field and 5 years of relevant industry experience3+ years’ relevant large molecule CMC development experience Previous experience in drug substance development; prior experience in adeno-associated virus and/or lentivirus gene therapy process development preferredStrong 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 preferredProven leader that can effectively operate in a cross-functional, matrix environment and successfully manage multiple programs / priorities simultaneouslyAbility 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 forwardPotential of up to 10% travel

Preferred Qualifications:

Advanced degree in relevant scientific degree

Novartis Compensation and Benefit Summary:

The pay range for this position at commencement of employment is expected to be between $114,100 – $211,900/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors