Scientist - Upstream Cell Culture

Location: Durham, NC (onsite; no visa sponsorship or relocation support available). This role requires presence in the Durham office 5 days per week.

About the Role

The Expert, Science & Technology – Upstream/Cell Culture is responsible for cell and gene therapy (AAV and LVV) upstream process development, optimization, scaling up/down, process characterization, technology transfer, and GMP manufacturing support.

Responsibilities

• Leads and supports cross-functional activities to plan, execute, and document experiments and early manufacturing that define processes and methods for delivery to clinical and commercial sites.
• Designs and executes time-sensitive experiments and studies to advance product development from Research to Development to GMP manufacturing, capturing related data and knowledge.
• Maintains awareness of novel biochemical and biophysical technologies for gene therapy production and characterization; stays updated with scientific literature and developments in the field.
• Applies understanding of regulatory expectations to process development strategies, contributes to process risk assessments, and justifies development strategies and experiment designs.
• Designs and applies DOE and QbD studies to develop, refine, optimize, and characterize cell culture and vector production processes.
• Executes experiments, troubleshoots processes and equipment, and conducts laboratory studies to enhance gene therapy manufacturing technologies (e.g., media development, bioreactor fed-batch and perfusion process development, optimization, and scale-up).
• Supports initiatives for new technology development and continuous improvement projects.
• Provides support for process, analytical, and characterization knowledge related to the production of gene therapy products and raw materials.
• Maintains records of collaborative relations with groups such as research and development, analytical development, and pilot-scale operations.
• Ensures all documentation and reports are accurate, complete, and suitable for supporting production, characterization, and regulatory filings.
• Writes detailed experimental protocols, develops Bill of Materials (BOM), executes and documents experimental studies according to SOPs or established practices, reviews, and reports data.
• Creates and revises SOPs for equipment and process operations.
• Leads the authoring of technical reports and CMC sections for regulatory filings.

Requirements

• Bachelor’s degree in biochemistry, chemical engineering, bioengineering, or a related technical field with 4–6 years of relevant experience; or Master’s with 2–4 years; or PhD with 0–2 years.
• Extensive experience with the production of viruses or biologics from mammalian expression systems.
• Hands-on experience with different cell lines, bioreactors, and scale-down models.
• Organized and systematic approach to viral or biologic production.
• Ability to multi-task and meet tight timelines.
• Knowledge of biopharmaceutical purification processes.
• Proficiency in statistical analysis principles and Design of Experiment (DoE).
• Ability to analyze data to make data-driven decisions and progress development strategies.
• Innovative mindset with a focus on continuous improvement.
• Excellent team player with strong communication skills.
• Knowledge of viral cell/gene therapy and prior experience with AAV and LVV process development is preferred.
• Fluency in English.

Pay

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 relevant skills and experience. Upon joining, salary will be reviewed periodically. Novartis may adjust the published salary range based on company and market factors.

Benefits

• Performance-based cash incentive and eligibility for annual equity awards.
• Comprehensive benefits package including health, life, and disability benefits.
• 401(k) with company contribution and match.
• Generous time off package including vacation, personal days, holidays, and other leaves.