Gene Therapy Downstream Process Lead

NCBioImpact; Durham (NC); On-site; USD 94,000 - 174,000; Full time

Job summary

Novartis in Durham, North Carolina is seeking a Scientist - Downstream Process Development to lead downstream development on a gene therapy program, performing hands-on operations at small and large scale while coordinating with cross-functional teams.

The role requires a strong background in downstream process development for biologics or gene therapy, with DoE and statistical analysis experience. This onsite position offers a competitive salary and comprehensive benefits.

Qualifications

• Bachelor’s degree in biological sciences, pharmaceutical sciences, chemical engineering, or a related technical field with 4 years of relevant experience; Master’s with 2 years; or PhD with 0–2 years of relevant experience.
• Hands-on downstream process development for biologics, viral vectors, or gene therapy modalities.
• Experience with downstream unit operations such as chromatography, depth filtration, tangential flow filtration, ultracentrifugation, impurity clearance, and adventitious virus clearance.
• Proficiency in statistical analysis principles and data-driven decision-making, with working knowledge of DoE.
• Demonstrated ability to lead technical activities, independently plan and execute studies, solve complex process development challenges, and deliver scientific objectives within timelines.
• Strong communication skills and cross-functional collaboration.
• Innovative mindset with commitment to continuous improvement.

Responsibilities

• Lead downstream functional development for early- and mid-phase programs on the Drug Substance Sub-Team.
• Design, execute, and interpret downstream process development studies for AAV and LVV modalities.
• Perform hands-on downstream operations at small and large scale to deliver high-quality results.
• Apply statistical analysis to study results and inform development strategy.
• Stay current with scientific advances and evaluate new technologies.
• Contribute to standards and platform development; author reports and regulatory submissions.
• Present study results and recommendations to stakeholders.
• Provide technical guidance to team members and foster collaboration.
• Coordinate lab activities and resource needs with cross-functional partners.

Skills

Downstream PD

DoE

Statistical analysis

Cross-functional

Leadership

Communication

Innovation

Education

Bachelor's degree

Master's degree

PhD

Job description

Novartis in Durham, North Carolina is seeking a Scientist - Downstream Process Development to lead downstream development on a gene therapy program, performing hands-on operations at small and large scale while coordinating with cross-functional teams.

The role requires a strong background in downstream process development for biologics or gene therapy, with DoE and statistical analysis experience. This onsite position offers a competitive salary and comprehensive benefits.