Senior Scientist, Process Science - Downstream

Location
San Diego, CA, US
Posted
Jul 07, 2021
Ref
6162
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Overview

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapies are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

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.

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

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.