Scientist - Downstream Process Development

Job Description Summary Location: Durham, North Carolina #onsite Relocation Support: This role is based in Durham, North Carolina, United States. Novartis is unable to offer relocation support: please only apply if accessible. The Scientist - Downstream Process Development will serve as a downstream functional lead on a gene therapy program, representing downstream process development on the Drug Substance Sub-Team. This role is responsible for defining and advancing program-specific downstream development plans; independently designing, executing, and interpreting studies; and performing hands-on process operations at both small scale and large scale. The Scientist will collaborate with cross-functional partners to deliver program objectives, evaluate new technologies, and contribute to technical best practices within the downstream group.   Job Description Major Accountabilities: • Serve as the downstream functional lead for early- and mid-phase programs, representing the function on the Drug Substance Sub-Team and driving downstream development plans, technical recommendations, and deliverables in alignment with program strategy. • Independently design, execute, and interpret downstream process development studies for AAV and LVV modalities across pre-clinical and clinical-stage assets. • 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. • Stay current with scientific and engineering advances and evaluate new technologies and innovative approaches relevant to viral vector downstream process development. • Apply technical standards and best practices and contribute to continuous improvement and platform development efforts. • Independently author technical reports, summarize process development outcomes, and contribute downstream content to regulatory filings, including IND submissions. • Present study results and technical recommendations to internal and external stakeholders in cross-functional forums. • Provide technical guidance and share expertise with team members to support study execution and foster an innovative, collaborative, and scientifically rigorous culture. • Coordinate laboratory activities and resource needs for assigned studies and collaborate with cross-functional partners to enable efficient execution. Essential Requirements: • Bachelor’s degree in biological sciences, pharmaceutical sciences, chemical engineering, or a related technical field with 4 years of relevant experience; Master’s degree with 2 years of relevant experience; or PhD with 0–2 years of relevant experience. • Strong technical background in downstream process development for biologics, viral vectors, or gene therapy modalities, with hands-on experience designing, executing, and interpreting process development studies. • 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 and experience in Design of Experiments (DoE). • Demonstrated ability to lead technical activities, independently plan and execute studies, solve complex process development challenges, and deliver scientific objectives within agreed timelines. • Strong communication skills and experience coordinating technical work in a cross-functional setting, with the ability to communicate recommendations clearly and collaborate effectively. • Innovative mindset with a