Job Title: Development Scientist II, Analytical Development and Clinical QC
Location: New Haven, Connecticut, United States
Job ID: R-224803
Date posted: 17/04/2025
About the Company:
AstraZeneca is a global, science-led biopharmaceutical company dedicated to improving the health and well-being of patients through the development of transformative therapies. With a focus on innovation in areas such as oncology, respiratory, cardiovascular, and rare diseases, AstraZeneca is committed to making a meaningful impact on the lives of patients worldwide.
Job Responsibilities:
Protein Characterization:
Lead and perform protein characterization by LC/MS, including method development and analysis using various mass spectrometry instruments (HPLC/UPLC ESI-ToF, ESI-Orbitrap, MALDI-ToF)
Oversee and train associates on protein characterization methods
Independently develop protein characterization strategies, evaluating new technologies
Cross-functional Collaboration:
Participate in cross-functional development teams and lead scientific/technical problem-solving efforts
Author CMC sections for regulatory filings, technical reports, protocols, and operating procedures
Manage activities of external research laboratories
Leadership and Training:
Provide leadership and guidance on laboratory practices, training personnel on protein characterization methods
Ensure compliance with GLP and quality guidelines, leading process improvements
Project Planning and Execution:
Plan and execute laboratory commitments, adjusting to changing priorities
Maintain a focus on the overall project, prioritizing work and ensuring alignment with project goals
Required Qualifications:
Education:
PhD in Biochemistry, Chemistry, or a related discipline
Experience:
Minimum of 2+ years of experience in protein characterization by LC/MS
Strong background in method development, scientific problem-solving, and the use of multiple mass spectrometry platforms
Skills and Abilities:
In-depth understanding of GLP and quality guidelines
Strong leadership and organizational skills to manage teams and laboratory activities
Ability to work comfortably in a controlled environment with biological, infectious, and hazardous materials
Excellent communication skills to collaborate effectively with teams
Preferred Qualifications:
Experience:
In-depth knowledge of charge variant analysis
Experience with additional non-MS methods for testing biotherapeutics
Familiarity with assay development, optimization, qualification, and validation for biotherapeutics
Experience working with CROs for assay development and sample testing
Why Join AstraZeneca:
Opportunity to work on cutting-edge projects in the biopharmaceutical industry
Collaborate with experts across academia, biotech, and industry to push the boundaries of science
Build a meaningful career in a diverse, inclusive, and dynamic work environment
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