Posted 17 hours ago
Development Scientist III, Analytical Development and Clinical Quality Control
AstraZeneca
Requirements
Ph.D. or Master's in Biochemistry, Biology, or related field, 6+ years analytical method development experience, Experience with ELISA, enzymatic, and cell-based assays, Knowledge of cGMP, ICH, USP, and WHO guidelines, Proficiency in MS Office, JMP, and SoftMax Pro, Ability to travel up to 20%
Skills
BiochemistryELISAGMPChemistryBiotechnologyMicrobiologyHPLCLIMS
About the role
Responsibilities
- Develop, optimize, and qualify bioassays to evaluate biological, biochemical, and cellular activities for therapeutic proteins
- Manage phase-appropriate qualification for process-derived impurity methods to support product release and regulatory filings
- Author SOPs, study plans, protocols, and method development/qualification reports
- Draft IND and BLA sections for regulatory filings and respond to health authority queries
- Lead cross-functional scientific problem-solving efforts and present technical findings to stakeholders
- Explore innovative technologies and automation to improve method throughput and efficiency
- Support method transfer, validation, and troubleshooting between internal and external laboratories
Requirements
- Ph.D. or Master's degree in Biochemistry, Molecular and Cellular Biology, Immunology, Chemistry, Bioengineering, or a related discipline
- Minimum of 6+ years of analytical method development and qualification experience in a pharmaceutical or biotechnology setting
- Extensive experience with ELISA binding assays, enzymatic assays, cell-based assays, and process-derived impurity methods
- Strong knowledge of cGMP, ICH, USP, and WHO regulatory guidelines
- Proficiency in MS Office, JMP, and SoftMax Pro
- Ability to travel up to 20% for on-site training and troubleshooting
- Ability to work in a laboratory environment, including handling biological and hazardous materials
Preferred Qualifications
- Experience with microbiology assays such as bioburden, endotoxin, and sterility
- Previous experience in a technical lead or people management role
- Knowledge of other analytical methods including LC, CE, and compendial methods
About the Company
AstraZeneca's Alexion division is dedicated to transforming the lives of patients with rare diseases. We foster an environment where innovation thrives, combining an entrepreneurial spirit with a commitment to scientific excellence and collaborative growth.
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Get started — it's freeDevelopment Scientist III, Analytical Development and Clinical Quality Control
AstraZeneca · New Haven
