GT Drug Substance Product Leader

Band

Level 4

Job Description Summary

Internal job title: Senior Expert Science & Technology

In this vital role the Senior Expert Drug Substance Product Leader will be responsible for leading early through latestage drug substance development of the Novartis Adenoassociated 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.

The ideal location for this role is Durham NC but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote all home office expenses and any travel/lodging to specific Durham for periodic live meetings will be at the employees expense. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require up to 10% travel.

Job Description

Key Responsibilities

• Lead early through latestage development of the Novartis Adenoassociated 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. programmanagement 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.

Role Requirements:

• Bachelors degree in relevant scientific field and 5 years of relevant industry experience
• 3 years relevant large molecule CMC development experience
• Previous experience in drug substance development; prior experience in adenoassociated 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 crossfunctional 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% 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 $114100 $211900/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 signon 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 atwill 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

EEO Statement:

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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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 email to call 1 (877)and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Range

$114100.00 $211900.00

Skills Desired

Coaching Skills Data Science Environment Experiments Design Health And Safety (Ehs) Laboratory Equipment Manufacturing Process Materials Science Process Simulation Sop (Standard Operating Procedure) Technical Writing Waterfall Model