Associate Scientist I, GMP Bioprocess Development (Downstream) - 168141
Role Summary
The Associate Scientist will support the downstream development, tech transfer, and GMP execution of derived and vetted processes to produce innovative vaccine products in support of Phase I clinical trials. This position will be involved in bioprocess development and GMP production, including lab scale downstream process development, scale up and tech transfer of processes into the GMP environment along with GMP execution support with associated regulatory compliance.
Responsibilities
- Work interpedently yet collaboratively to perform downstream lab scale process development activities to include:
- Preparation and operation of disparate modes of process chromatography
- AEX, CEX, HIC, Mixed Mode, Affinity, SEC, etc.
- Tangential flow filtration (UF/DF)
- Clarification approaches (depth filtration, centrifugation, and flocculation)
- Nanofiltration and depth filtration
- Buffer formulation and preparation
- Viral clearance execution
- Document development and GMP activities compliant with regulatory requirements
- Support and execute cGMP production, including equipment and material readiness (technical transfer), to meet project needs
- Support GMP investigations via root cause assessments and supporting empirical studies
- Compile data, summarize analyses and present experimental results to facilitate collaborative decision making in regards to product safety, quality, facility fit and process capacities
- Draft and review technical development reports
Preferred Skills and Experience
- 2 years relevant experience in the biopharmaceutical industry or equivalent
- GMP experience is preferred
- Basic chromatography and filtration understanding
- Basic analytical knowledge and hands on experience with analytical techniques to support downstream activities (SDS-PAGE, UV-Vis spectroscopy and SEC).
- Must have the ability to work independently yet collaboratively to execute downstream processes with guidance from other scientists and the line manager
- Demonstrated ability to solve moderate complex problems with guidance from other scientists and the line manager
- Demonstrated sufficient scientific impendence with rigor and cross-functional collaboration
- Oral and written communication skills
Minimum Requirements
- Education: Bachelor's degree in a science, engineering, or related field
- Experience: None