Scientist - Upstream Cell Culture
Novartis
12 hours ago
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/support cross-functional planning, execution, and documentation of experiments and early manufacturing defining the process and delivery method for clinical/commercial sites.
- Design and execute time-sensitive experiments/studies; capture data/knowledge to advance products from Research to Development to GMP manufacturing.
- Stay current on novel technologies; apply regulatory expectations to process development strategies; contribute to risk assessments; justify development strategies and experiment designs.
- Apply DOE and QbD to develop/refine/optimize/characterize cell culture and vector production; troubleshoot processes/equipment; conduct studies (e.g., media development, fed-batch/perfusion bioreactor development, optimization/scale-up).
- Support new technology development and continuous improvement.
- Provide process/analytical/characterization knowledge for gene therapy products and required raw materials.
- Maintain collaboration records with research, analytical development, and pilot scale operations.
- Ensure documentation/reports are accurate and suitable for production, characterization, and regulatory filings.
- Write experimental protocols; develop 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 in biochemistry/chemical engineering/bioengineering (4–6 years) or MS (2–4) or PhD (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 multitask and meet tight timelines.
- Knowledge of biopharmaceutical purification processes.
- Proficient in statistics; working knowledge of Design of Experiments (DoE).
- Ability to analyze data for data-driven decisions; continuous improvement mindset; strong communication/team skills.
- Preferred: knowledge of viral cell/gene therapy and prior AAV & LVV process development experience.
Language
- English.
- 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/support cross-functional planning, execution, and documentation of experiments and early manufacturing defining the process and delivery method for clinical/commercial sites.
- Design and execute time-sensitive experiments/studies; capture data/knowledge to advance products from Research to Development to GMP manufacturing.
- Stay current on novel technologies; apply regulatory expectations to process development strategies; contribute to risk assessments; justify development strategies and experiment designs.
- Apply DOE and QbD to develop/refine/optimize/characterize cell culture and vector production; troubleshoot processes/equipment; conduct studies (e.g., media development, fed-batch/perfusion bioreactor development, optimization/scale-up).
- Support new technology development and continuous improvement.
- Provide process/analytical/characterization knowledge for gene therapy products and required raw materials.
- Maintain collaboration records with research, analytical development, and pilot scale operations.
- Ensure documentation/reports are accurate and suitable for production, characterization, and regulatory filings.
- Write experimental protocols; develop 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 in biochemistry/chemical engineering/bioengineering (4–6 years) or MS (2–4) or PhD (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 multitask and meet tight timelines.
- Knowledge of biopharmaceutical purification processes.
- Proficient in statistics; working knowledge of Design of Experiments (DoE).
- Ability to analyze data for data-driven decisions; continuous improvement mindset; strong communication/team skills.
- Preferred: knowledge of viral cell/gene therapy and prior AAV & LVV process development experience.
Language
- English.