Scientist, Upstream/Cell Culture

Job Description Summary #LI-onsite Internal Title: Expert Science & Technology Location: Durham, NC 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 Key Responsibilities 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 production of gene therapy products, and the raw materials needed to make them. Tracks 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 using in support of production, characterization, and regulatory filings. Writes detailed experimental protocols, develop Bill of Materials (BOM), executes and documents experimental studies according to Standard Operating Procedures (SOPs) or established practices, review and report data. Creates and revise SOPs for equipment and process operations. Lead the authoring of technical reports and CMC sections for regulatory filings. Essential Requirements: Bachelor's degree in biochemistry, chemical engineering, bioengineering, or related technical field with 4 years relevant experience; or Master's with 2 years relevant experience; or PhD with academic experience (Recent PhD welcome to apply). 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 is essential. 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 and further progress development strategies. Innovative with a continuous improvement mindset. Excellent team player with good communication skills. Excellent team player with good communication skills. Desired Requirements Knowledge with a variety of biopharmaceutical purification processes is desired Knowledge of viral cell/gene therapy and previous experience with LVV process development is preferred. 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 and other leaves. To learn more about the culture, rewards and benefits we offer our people click here. 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 us.reasonableaccommodations@novartis.com or call +1(877)395-2339 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 Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing peoples lives. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .