Scientist - Upstream Cell Culture
Novartis
August 19, 2026
On-site
Durham, NC
Operations
Role Purpose
The Expert, Science & Technology – Upstream/Cell Culture, is responsible for cell & gene therapy (AAV and LVV) upstream process development, optimization and scaling up/down, process characterization, technology transfer and GMP manufacturing support.
Major accountabilities
- Lead and support cross-functional teams to plan, execute, and document experiments and early manufacturing defining the process and delivery method to clinical/commercial sites.
- Design and execute time-sensitive experiments/studies; capture data and knowledge to advance products from Research to Development to GMP manufacturing.
- Stay current on biochemical/biophysical technologies and literature; apply regulatory expectations; contribute to process risk assessments; justify development strategies and experiment designs.
- Use DOE and QbD to develop/refine/optimize/characterize cell culture and vector production processes; execute experiments; troubleshoot process/equipment; conduct lab studies (media development; fed-batch/perfusion bioreactor development, optimization, scale-up).
- Support new technology development and continuous improvement projects.
- Provide process/analytical/characterization support for gene therapy products and raw materials.
- Ensure accurate, complete documentation for production/characterization and regulatory filings.
- Write protocols; develop Bill of Materials (BOM); execute/document studies per SOPs; review/report data.
- Create/revise SOPs for equipment and process operations.
- Author technical reports and CMC sections for regulatory filings.
Minimum requirements
- BS (biochemistry, chemical engineering, bioengineering, or related) with 4–6 years; or MS with 2–4; or PhD with 0–2.
- Extensive experience producing virus/biologics from mammalian expression systems.
- Hands-on experience with cell lines, bioreactors, and scale-down models.
- Organized/systematic approach; ability to multi-task and meet tight timelines.
- Knowledge of biopharmaceutical purification processes.
- Proficient in statistical analysis and DoE.
- Ability to analyze data for data-driven decisions; continuous improvement mindset; strong communication/teamwork.
- Preferred: knowledge of viral cell/gene therapy and experience with AAV & LVV process development.
Language
- English.
Compensation/benefits (as stated)
- Salary range: $93,800–$174,200/year; performance-based cash incentive; potential eligibility for annual equity awards; comprehensive health and 401(k); time off.
Application instructions
- Not specified.
The Expert, Science & Technology – Upstream/Cell Culture, is responsible for cell & gene therapy (AAV and LVV) upstream process development, optimization and scaling up/down, process characterization, technology transfer and GMP manufacturing support.
Major accountabilities
- Lead and support cross-functional teams to plan, execute, and document experiments and early manufacturing defining the process and delivery method to clinical/commercial sites.
- Design and execute time-sensitive experiments/studies; capture data and knowledge to advance products from Research to Development to GMP manufacturing.
- Stay current on biochemical/biophysical technologies and literature; apply regulatory expectations; contribute to process risk assessments; justify development strategies and experiment designs.
- Use DOE and QbD to develop/refine/optimize/characterize cell culture and vector production processes; execute experiments; troubleshoot process/equipment; conduct lab studies (media development; fed-batch/perfusion bioreactor development, optimization, scale-up).
- Support new technology development and continuous improvement projects.
- Provide process/analytical/characterization support for gene therapy products and raw materials.
- Ensure accurate, complete documentation for production/characterization and regulatory filings.
- Write protocols; develop Bill of Materials (BOM); execute/document studies per SOPs; review/report data.
- Create/revise SOPs for equipment and process operations.
- Author technical reports and CMC sections for regulatory filings.
Minimum requirements
- BS (biochemistry, chemical engineering, bioengineering, or related) with 4–6 years; or MS with 2–4; or PhD with 0–2.
- Extensive experience producing virus/biologics from mammalian expression systems.
- Hands-on experience with cell lines, bioreactors, and scale-down models.
- Organized/systematic approach; ability to multi-task and meet tight timelines.
- Knowledge of biopharmaceutical purification processes.
- Proficient in statistical analysis and DoE.
- Ability to analyze data for data-driven decisions; continuous improvement mindset; strong communication/teamwork.
- Preferred: knowledge of viral cell/gene therapy and experience with AAV & LVV process development.
Language
- English.
Compensation/benefits (as stated)
- Salary range: $93,800–$174,200/year; performance-based cash incentive; potential eligibility for annual equity awards; comprehensive health and 401(k); time off.
Application instructions
- Not specified.