Novartis
Healthcare
Scientist-UpstreamCellCulture
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Scientist - Upstream Cell Culture at Novartis. Skills: Cell culture, Gene therapy, Process development, AAV & LVV. Lead and support activity with cross-functional organizations. Plan, execute, and document experiments”
Industry & Context.
Troubleshoot process and equipment; Data-driven decisions
Must be accessible for Durham, NC location, Required to be in Durham, NC office 5x/week
What They're Looking For.
Must Have
Bachelor's in biochemistry, chemical engineering, bioengineering, or related technical field with 4-6 years relevant experience or Master's with 2-4 or PhD with 0-2, Extensive experience with production of virus or biologics from mammalian expression systems, Hands on experience with different cell lines, bioreactors, and scale-down model, Organized and systematic approach to viral or biologic production, Ability to multi-task and meet tight timelines, Knowledge with a variety of biopharmaceutical purification processes, Proficient in statistical analysis principles and approaches, Working knowledge and experience with Design of Experiment (DoE), Ability to analyze data to make date-driven decisions, Innovative with a continuous improvement mindset, Excellent team player with good communication skills
Nice to Have
Knowledge of viral cell/gene therapy, Previous experience with AAV & LVV processes development
What You'll Do.
Lead and support activity with cross-functional organizations
and document experiments
Define the process and method of delivery
Design and execution of time-sensitive experiments
Capture related data and knowledge
Advance development products from Research to Development to
Maintain awareness of novel biochemical and biophysical technologies
Keep up to date with scientific literature
Apply understanding of regulatory expectations
Contribute to process risk assessments
Justify development strategies and experiment designs
Design and apply DOE and QbD studies
optimize and characterize cell culture and
Execute experiments and troubleshoot process and equipment
Conduct laboratory studies to enhance gene therapy manufacturing
Support initiatives for new technology development
Support continuous improvement projects
Provide support for process
and characterization knowledge
Track records of collaborative relations
Ensure all documentation and reports are accurate
Write detailed experimental protocols
Develop Bill of Materials (BOM)
Execute and document experimental studies
Review and report data
Create and revise SOPs for equipment and process
Lead the authoring of technical reports
Lead the authoring of CMC sections for regulatory
How You'll Work.
Team & Collaboration
Cross-functional organizations; Research and development; Analytical development; Pilot scale operations
Full Job Description
**Job Description Summary** Location: Durham, NC #onsite Novartis will not sponsor visas for this position. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. This role is required to be in our Durham, NC office 5x/week. 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. **Job Description** **Major accountabilities:** * Leads and support activity with cross-functional organizations to plan, execute, and document experiments and early manufacturing that define the process, and method of delivery to the clinical and commercial sites. * Design and execution of time-sensitive experiments, studies, and capturing related data and knowledge, to advance the development products from Research to Development to GMP manufacturing. * Maintains constant awareness of novel biochemical and biophysical technologies for gene therapy production and characterization. Keeps up to date with the scientific literature and developments in the field. Applies understanding of regulatory expectations to process development strategies. Contributes to process risk assessments. 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 and troubleshoot process and equipment. Conducts laboratory studies to enhance gene therapy manufacturing technologies, capabilities and processes (such as 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
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