Scientist - Downstream Process Development

Novartis•Durham, CA

1d•$93,800 - $174,200•Onsite

About The Position

The Scientist - Downstream Process Development serves as a downstream functional lead on a gene therapy program, representing downstream process development on the Drug Substance Sub-Team. The role defines and advances program-specific downstream development plans, independently designs, executes, and interprets studies, and performs hands-on process operations at small and large scale. The Scientist collaborates with cross-functional partners to deliver program objectives, evaluates new technologies, and contributes to technical best practices within the downstream group. The position supports early- and mid-phase programs and downstream development for AAV and LVV modalities across pre-clinical and clinical-stage assets. It involves analyzing study results, authoring technical reports, contributing downstream content to regulatory filings including IND submissions, and presenting findings and recommendations to stakeholders. The role also provides technical guidance to team members and coordinates laboratory activities and resources for assigned studies. This onsite position is based in Durham, North Carolina. Novartis is unable to offer relocation support. The expected salary range is $93,800 to $174,200 per year. Compensation includes a performance-based cash incentive and, depending on role level, potential eligibility for annual equity awards. Eligible US-based employees receive health, life, and disability benefits, a 401(k) with company contribution and match, and paid time off including vacation, personal days, and holidays.

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, including 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 and commitment to continuous improvement and applying new ideas to downstream process development.

Nice To Haves

Knowledge of viral gene therapy and experience with AAV or LVV downstream process development.
Knowledge of current Good Manufacturing Practices (cGMP) requirements and their application in a process development environment.

Responsibilities

Lead downstream technical activities for early- and mid-phase programs, representing the function on the Drug Substance Sub-Team and driving development plans, technical recommendations, and deliverables aligned with program strategy.
Design, execute, and interpret downstream process development studies for AAV and LVV modalities across pre-clinical and clinical-stage assets.
Conduct hands-on downstream process operations at small and large scale and deliver high-quality experimental outputs within program timelines.
Analyze process study results using a statistical and data-driven approach, draw scientifically sound conclusions, and inform development strategy.
Track scientific and engineering advances and evaluate technologies and approaches relevant to viral vector downstream process development.
Apply technical standards and best practices and contribute to continuous improvement and platform development.
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 a collaborative, scientifically rigorous culture.
Coordinate laboratory activities and resource needs for assigned studies and collaborate with cross-functional partners to enable efficient execution.