Expert Science & Technology, Downstream Process Development

Band Level 3 Job Description Summary #LI-Onsite Internal Job Title: Expert Science & Technology Location: Durham, NC The Expert Science & Technology (Downstream) is responsible for the gene therapy downstream process development for designing and executing downstream process development activities, as well as performing downstream process operations at both small scale and large scale to support pipeline research and pre-clinical studies. Job Description Key Responsibilities: Advances complex downstream process development efforts Independently designs and executes gene therapy downstream process development studies Performs experiments at both large-scale and small-scale to support pre-clinical, clinical and commercial programs. Ensures these experiments are done in a timely fashion with high quality Stays current with the latest scientific and engineering developments in the field Leverages strong understanding of biologics downstream process to evaluate and introduces new technologies and innovative ideas related to downstream process development Analyzes and interprets experimental data from process studies with strong statistical mindset. Makes decisions based on statistically sound conclusions Presents study results internally and externally in a cross-functional setting. Independently authors technical reports of studies of process development activities and laboratory experiments, such as development report, study report, investigational summary report, etc. Collaborates with cross-functional groups to advance pipeline programs. Provides support for regulatory filings and author sections in IND filings Essential Requirements: Bachelor's degree in biological sciences, pharmaceutical sciences or related technical field with at least 4 years relevant experience or Master's degree in biological sciences, pharmaceutical sciences or a related technical field with at least 2 years of experience, or a PhD in a relevant field (recent PhD graduates with applicable experience will be considered). Comprehensive experience with a variety of biopharmaceutical purification processes such as chromatographic separation, depth filtration, precipitation & flocculation, tangential flow filtration, adventitious viral clearance, ultracentrifugation, and impurity clearance 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. Good communication skills with project management experience in cross-functional setting Desirable Requirements: Knowledge of current Good Manufacturing Practices (cGMP) requirements and their indication in process development environment Knowledge of viral gene therapy and previous experience with AAV or LVV downstream process development is a plus Experience with mechanistic modeling a plus 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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. 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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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. https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings 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 .