The Senior Scientist is responsible for delivering technology-based analytical characterization data for CQA (critical quality attribute) assessment, comparability, peak identification, and investigative research. Core technologies include chromatography, electrophoresis, and related techniques.
The Senior Scientist will manage a technical team, and partner with various functional lines such as bioassay, biophysical characterization, analytical methods, and process development in delivering solid analytical characterization data package. Scope of this position include a wide range of development programs in biologics portfolio of proteins and fixed dose combinations.
The position provides exciting opportunity to be involved in early and late stage clinical development programs, progress the assets to marketing approval, and bring life-saving medicines to patients who are waiting. It also offers possibility of getting involved in diverse modalities including antibody, fusion protein, oligos, and fixed dose combinations. The Senior Scientist role provides strong growth opportunities and career development. Qualifications: Competencies
- PhD (or MS) in analytical sciences, biochemistry, pharmaceutical sciences, biology, or related disciplines, and 6 years (or 10 for MS) of experience in biologics CMC development
- Expertise in analytical and biochemical techniques including chromatography (size-exclusion, reverse-phase, ion-exchange, hydrophobic/hydrophilic interaction), electrophoresis (CE-SDS, iCIEF).
- Expertise and direct experience in measuring level of quality attributes such as size (aggregates, fragments), charge, glycans, protein content, protein modifications, and others.
- Experience in resolving technical issues with a collaborative mindset and aptitude in innovation
- Good interpersonal and communication skills
- Desired: Knowledge of biological function, protein structure, and biologics degradation
- Desired: Knowledge of biologics CMC and analytical development from pre-clinical through clinical to commercialization