Scientist - Downstream Process Development

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

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 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

EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$93,800.00 - $174,200.00