Scientist - Downstream Process Development
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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.
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 commitment to continuous improvement and applying new ideas to downstream process development.Desired Requirements: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.The salary for this position is expected to range between $93,800 and $174,200 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays an
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