Expert Science & Technology, Downstream Process Development

Novartis

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profile Job Location:

Durham, NC - USA

profile Yearly Salary: $ 93800 - 174200
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

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:
Bachelors degree in biological sciences pharmaceutical sciences or related technical field with at least 4 years relevant experience or Masters 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 $93800 and $174200 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 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 or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.


Salary Range

$93800.00 - $174200.00


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
Job Description Summary#LI-OnsiteInternal Job Title: Expert Science & TechnologyLocation: Durham NCThe Expert Science & Technology (Downstream) is responsible for the gene therapy downstream process development for designing and executing downstream process development activities as well as performi...
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Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.

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