Expert - Science & Technology (Downstream Process Development)
About The Position
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. This role involves advancing complex downstream process development efforts as a technical lead within a cross-functional team, independently designing and executing gene therapy downstream process development studies, and performing experiments at various scales to support pre-clinical, clinical, and commercial programs. The expert is expected to stay current with scientific and engineering developments, leverage understanding of biologics downstream processes to introduce new technologies, analyze and interpret experimental data with a strong statistical mindset, and make data-driven decisions. Responsibilities also include presenting study results, authoring technical reports, collaborating with cross-functional groups, and providing support for regulatory filings.
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 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
Nice To Haves
- 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
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 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
Benefits
- health, life and disability benefits
- a 401(k) with company contribution and match
- a variety of other benefits
- a generous time off package including vacation, personal days, holidays and other leaves
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Number of Employees
5,001-10,000 employees
