Downstream Process Development Scientist — Gene Therapy

Novartis AG; North Carolina; On-site; USD 94,000 - 174,000; Full time

Job summary

Novartis in Durham, NC, is seeking a Scientist - Downstream Process Development to lead downstream development on a gene therapy program. You will design, execute, and interpret downstream studies for AAV and LVV, and perform hands-on operations at small and large scales within a cross-functional team.

You will apply DoE and statistical analyses to guide strategy, stay current with advances, and contribute to regulatory submissions with technical reports.

Qualifications

• Bachelor's degree in biological sciences, pharmaceutical sciences, chemical engineering, or a related field with 4 years of relevant experience; Master's with 2 years; PhD with 0–2 years.
• Strong technical background in downstream process development for biologics, viral vectors, or gene therapy modalities, with hands-on experience.
• 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 Design of Experiments (DoE).
• Demonstrated ability to lead technical activities, independently plan and execute studies, and deliver scientific objectives within timelines.
• Strong communication skills and experience coordinating technical work in cross-functional settings.
• Innovative mindset with commitment to continuous improvement in downstream process development.

Responsibilities

• Serve as the downstream functional lead for early- and mid-phase programs and drive development plans.
• Independently design, execute, and interpret downstream process development studies for AAV and LVV modalities.
• Perform hands-on downstream process operations at both small and large scales.
• Apply statistical and data-driven analysis to interpret study results and inform development strategy.
• Stay current with scientific and engineering advances and evaluate new technologies.
• Apply standards and contribute to continuous improvement and platform development.
• Author technical reports and contribute downstream content to regulatory filings including INDs.
• Present study results and recommendations to stakeholders in cross-functional forums.
• Provide guidance to team members to support study execution and foster collaboration.
• Coordinate laboratory activities and resource needs for assigned studies.

Skills

Downstream development

Statistical analysis

DoE (Design of Experiments)

Cross-functional collaboration

Education

Bachelor's degree in biological sciences / related field

Master's degree

PhD

Tools

Chromatography

Depth filtration

Tangential flow filtration

Ultracentrifugation

Impurity clearance

Job description

Novartis in Durham, NC, is seeking a Scientist - Downstream Process Development to lead downstream development on a gene therapy program. You will design, execute, and interpret downstream studies for AAV and LVV, and perform hands-on operations at small and large scales within a cross-functional team.

You will apply DoE and statistical analyses to guide strategy, stay current with advances, and contribute to regulatory submissions with technical reports.