Senior Scientist - Downstream Process Development

Summary
Role type:
Full time onsite,

Location:

Durham, North Carolina, United States
Relocation Support:
Yes
Join the team shaping the future of Cell and Gene Therapy and help bring transformational medicines to patients worldwide. As a Senior Scientist – Downstream Process Development, you will play a critical role in advancing viral vector technologies across adeno-associated virus (AAV) and lentiviral vector (LVV) platforms. Combining scientific expertise, innovation, and hands-on laboratory leadership, you will drive process development strategies that support breakthrough therapies from pre-clinical development through clinical manufacturing.

This is a unique opportunity to influence cutting-edge science, collaborate with world-class experts, and accelerate the delivery of life-changing treatments to patients with urgent unmet needs.

Key Responsibilities
You will serve as the downstream technical lead for one or more gene therapy programs. This role is responsible for defining the overall downstream development plan for assigned gene therapy programs; designing, executing, and interpreting downstream process development studies; performing hands-on process operations at both small scale and large scale; and collaborating with cross-functional teams to advance AAV and LVV programs from pre-clinical development through clinical manufacturing.

• Perform hands-on downstream process operations at both small scale and large scale, delivering high-quality experimental outputs within program timelines.
• Apply a strong statistical and data-driven mindset to analyze process study results, draw scientifically sound conclusions, and inform development strategy.
• Drive downstream innovation by evaluating emerging technologies, current scientific advances, and state-of-the-field approaches relevant to viral vector process development.
• Promote adoption of technical standards, platform approaches, and best practices across multiple programs and modalities.
• Author technical reports, summarize process development outcomes, and contribute downstream content to regulatory filings, including IND submissions.
• Present study results, technical recommendations, and development strategies to internal and external stakeholders in cross-functional forums.
• Be a technical coach and mentor, fostering an innovative, collaborative, and scientifically rigorous culture.
• Present technical recommendations and mentor colleagues to foster scientific excellence and collaboration.

• Bachelor’s degree in biological sciences, pharmaceutical sciences, chemical engineering, or a related technical field with 8+ years of relevant experience;
  Master’s degree with 6+ years of relevant experience; or PhD with 4+ years of relevant experience.
• Strong technical background in downstream process development for biologics and/or viral vector-based therapies, with hands-on experience designing, executing, and interpreting process development studies.
• In-depth expertise across multiple downstream unit operations such as chromatography, depth filtration, precipitation or flocculation, tangential flow filtration, ultracentrifugation, impurity clearance, and adventitious virus clearance.
• Proficiency in statistical analysis principles, Design of Experiments (DoE), and data-driven decision-making.
• Proven ability to define technical plans, solve complex process development challenges, and deliver scientific objectives within program timelines.
• Demonstrated ability to influence cross-functional stakeholders, communicate technical recommendations clearly, and contribute to program strategy in a matrixed environment.
• Innovative mindset with experience advancing continuous improvement, technical standards, best practices, or platform approaches across programs.

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?

Benefits and Rewards: Learn about all…