Expert - Science & Technology (Downstream Process Development)

Job Description Summary

Location: Durham, North Carolina #onsite, 5x week
Novartis 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 us.reasonableaccommodations@novartis.com 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