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Durham, North Carolina, United States
Onsite
Not Available
Band
Level 4
Job Description Summary
Role type: Full time onsite, #LI-Onsite
Job Description
Key Responsibilities
You will serve as the downstream technical lead for one or more gene therapy programs. This role is responsible for defining the overall downstream development plan for assigned gene therapy programs; designing, executing, and interpreting downstream process development studies; performing hands-on process operations at both small scale and large scale; and collaborating with cross-functional teams to advance AAV and LVV programs from pre-clinical development through clinical manufacturing.
Other responsibilities will include:
Perform hands-on downstream process operations at both small scale and large scale, delivering high-quality experimental outputs within program timelines.
Apply a strong statistical and data-driven mindset to analyze process study results, draw scientifically sound conclusions, and inform development strategy.
Drive downstream innovation by evaluating emerging technologies, current scientific advances, and state-of-the-field approaches relevant to viral vector process development.
Promote adoption of technical standards, platform approaches, and best practices across multiple programs and modalities.
Author technical reports, summarize process development outcomes, and contribute downstream content to regulatory filings, including IND submissions.
Present study results, technical recommendations, and development strategies to internal and external stakeholders in cross-functional forums.
Be a technical coach and mentor, fostering an innovative, collaborative, and scientifically rigorous culture.
Present technical recommendations and mentor colleagues to foster scientific excellence and collaboration.
Essential Requirements
Bachelor’s degree in biological sciences, pharmaceutical sciences, chemical engineering, or a related technical field with 8+ years of relevant experience; Master’s degree with 6+ years of relevant experience; or PhD with 4+ years of relevant experience.
Strong technical background in downstream process development for biologics and/or viral vector-based therapies, with hands-on experience designing, executing, and interpreting process development studies.
In-depth expertise across multiple downstream unit operations such as chromatography, depth filtration, precipitation or flocculation, tangential flow filtration, ultracentrifugation, impurity clearance, and adventitious virus clearance.
Proficiency in statistical analysis principles, Design of Experiments (DoE), and data-driven decision-making.
Proven ability to define technical plans, solve complex process development challenges, and deliver scientific objectives within program timelines.
Demonstrated ability to influence cross-functional stakeholders, communicate technical recommendations clearly, and contribute to program strategy in a matrixed environment.
Innovative mindset with experience advancing continuous improvement, technical standards, best practices, or platform approaches across programs.
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
$119,700.00 - $222,300.00
Skills Desired
Data Science, Materials Science, Process Simulation, Technical Writing, Waterfall Model