Expert - Science & Technology (Downstream Process Development)
Healthcare Businesswomen’s Association, Raleigh, NC, United States
Job Description Summary
Location: Durham, North Carolina (on site, 5 days per 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.
Your Key Responsibilities
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 introduce new technologies and innovative ideas related to downstream process development
Analyzes and interprets experimental data from process studies with a 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, investigative 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 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 effectively leading a 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 implementation in a process development environment is a plus
Experience with mechanistic modeling is a plus
Salary
Salary range: $93,800 – $134,000 per year. The final salary offered will be determined based on 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.
Benefits
US‑based eligible employees 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. Employees are eligible for a generous time‑off package including vacation, personal days, holidays and other leaves. Compensation may include a performance‑based cash incentive and, depending on the level of the role, eligibility for annual equity awards.
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.
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Location: Durham, North Carolina (on site, 5 days per 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.
Your Key Responsibilities
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 introduce new technologies and innovative ideas related to downstream process development
Analyzes and interprets experimental data from process studies with a 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, investigative 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 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 effectively leading a 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 implementation in a process development environment is a plus
Experience with mechanistic modeling is a plus
Salary
Salary range: $93,800 – $134,000 per year. The final salary offered will be determined based on 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.
Benefits
US‑based eligible employees 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. Employees are eligible for a generous time‑off package including vacation, personal days, holidays and other leaves. Compensation may include a performance‑based cash incentive and, depending on the level of the role, eligibility for annual equity awards.
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.
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