Job Description Summary
Location: Durham, North Carolina #onsite, 5x weekNovartis 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
Role Purpose:
The 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
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 introduces 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 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. Providing support for regulatory filings and author sections in IND filings
Role Requirements
Bachelor's degree in biological sciences, pharmaceutical sciences, chemical engineering or related technical field with 4 years relevant experience, or Master's degree in in biological sciences, pharmaceutical sciences, chemical engineering or related technical field with 2 years of experience, or PhD with 0-2 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
Knowledge of current Good Manufacturing Practices (cGMP) requirements and their indication in process development environment is a plus
Experience with mechanistic modeling a plus
The salary for this position is expected to range between $93,800 and $134,000 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.
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 [email protected] 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
What We Do
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
