Senior Expert - Science & Technology (Downstream Process Development)

Job Description Summary

Internal Job Title: Senior Expert Science & Technology
Position is on-site in Durham, NC
#LI-Onsite

About the Role:
Join us in reimagining Cell and Gene Therapies and advancing scientific breakthroughs for patients with unmet medical needs. We transform the lives of people by developing innovative and life-changing medicines

The Senior Expert, Science & Technology (Downstream) is responsible as a technical lead in 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

Your Key Responsibilities:

Your responsibilities will include, but are not limited to:

• Advances complex downstream process development efforts as a technical lead within a cross-functional team across sites
• 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, ensuring 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 introduce new technologies and innovative ideas related to downstream process development
• Analyzes and interprets experimental data from process studies with strong statistical mindset, making decisions based on statistically sound conclusions
• Presents study results internally and externally in a cross-functional setting
• Independently authors technical reports for process development activities and laboratory experiments
• Collaborates with cross-functional groups to advance pipeline programs, providing support for regulatory filings and author sections in IND filings
• Leads and mentors technical team fostering innovative and collaborative culture
• Communicates effectively with diverse teams to coordinate lab activities and manage resources
   

*Multiple positions available

Role Requirements

• Bachelor's, biological sciences, pharmaceutical sciences, chemical engineering or related technical field with 8 years relevant experience, Master's with 6 years of experience, or PhD with 4 years of experience
• 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
• Proven team leader with previous experience of effectively leading technical group
• Innovative with a continuous improvement mindset
• Good communication skills with project management experience in cross-functional setting

Desired Requirements:

• Knowledge of viral gene therapy and previous experience with AAV or LVV downstream process development is a plus
• Experience with mechanistic modeling a plus

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining

to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. 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 are committed to building diverse teams, representative of the patients and communities we serve, and we strive