Scientist - Downstream Process Development

Novartis Group Companies; Durham (NC); On-site; USD 94,000 - 174,000; Full time

Benefits offered by this job

Health, life & disability benefits

401(k) with company match

Generous time off package

Job summary

Novartis AG in Durham, NC is seeking an experienced Downstream Process Development Lead for viral vector programs (AAV/LVV). You will design and execute downstream development studies, lead cross-functional teams, and deliver data-driven recommendations to support INDs.

The role requires strong hands-on experience with chromatography, filtration, and DoE, plus collaborative skills to drive program milestones in a fast-paced biotech environment.

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; or PhD with 0–2 years.
• 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 and DoE.
• Ability to lead technical activities and deliver scientific objectives within timelines.
• Strong communication and cross-functional collaboration capabilities.
• Innovative mindset and continuous improvement drive.

Responsibilities

• Serve as downstream functional lead for early- and mid-phase programs.
• Design, execute, and interpret downstream studies for AAV and LVV modalities.
• Perform hands-on downstream operations at small and large scale.
• Analyze study results with a data-driven mindset for strategy informs.
• Present results and recommendations to internal/external stakeholders.
• Coordinate laboratory activities and resource needs for studies.

Skills

Downstream process development

Design of Experiments (DoE)

Statistical analysis

Cross-functional leadership

Education

Bachelor's degree in biological sciences/pharmaceutical sciences/chemical engineering

Master's degree (related field)

PhD (related field)

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.

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

Skills Desired