Senior Scientist, Process Science - Downstream

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Senior Scientist, Process Science - Downstream, is responsible to be a technical lead in gene therapy downstream process development, 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.

Responsibilities

• Advances complex downstream process development efforts as a technical lead within a cross-functional team across sites.
• 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.
• Leads and mentors technical team fostering innovative and collaborative culture.
• Communicates effectively with diverse teams to coordinate lab activities and manage resources.
• Other related job duties as assigned.

Qualifications

• Bachelor's, biological sciences, pharmaceutical sciences or related technical field with 8 years relevant experience or Master's with 6 or PHD with 4.
• 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.
• 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 downstream process development is preferred.
• Up to 10% travel.

The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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