Development Scientist I, Analytical Development and Quality Control
AstraZeneca
AstraZeneca seeks a Development Scientist I to develop and optimize analytical methods for biotherapeutic characterization, with focus on capillary electrophoresis techniques. The role involves method validation, instrumentation oversight, regulatory support, and collaboration across R&D and manufacturing teams in a laboratory setting.
Responsibilities
- Develop, optimize, and qualify capillary electrophoresis methods to assess protein quality attributes and charge heterogeneity
- Supervise operation, maintenance, and troubleshooting of analytical instruments including Revvity LabChip and Protein Simple platforms
- Author SOPs, study plans, protocols, method reports, and draft regulatory filings
- Support method transfer and validation with internal/external labs and analytical technical transfer teams
- Serve as capillary electrophoresis subject matter expert and train junior lab personnel on specialized techniques
Requirements
- Ph.D. in Chemistry, Biochemistry, Chemical Engineering or related field with 0–2 years experience; or Master's with 4–6 years; or Bachelor's with 10+ years
- Scientific knowledge of protein characterization for monoclonal antibodies and glycoproteins
- Ability to work independently with scientific problem-solving approach to method development
- Capability to lift/carry 15–30 pounds, work with biological and hazardous materials, use PPE
- Willingness to travel up to 20% for on-site training and troubleshooting
- Protein/peptide analysis by gel or capillary electrophoresis experience in pharma/biotech is a plus
- Knowledge of cGMP and quality guidelines (ICH Q2, ICH Q14) is desired
Vacancy posted 2 days ago
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