Senior Scientist, Biologic Drug Product Development
AstraZeneca plc
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Job summary
AstraZeneca plc in New Haven seeks a Senior Scientist to lead research, design and execute studies for drug product process development of parenteral biologics. You will oversee DS/DP unit operations including freeze/thaw, sterile filling, filtration, visual inspection and related QC support, with hands-on biotherapeutics development experience.
The role emphasizes technology transfer, deviations and change control support, data analysis, and preparation of reports for regulatory filings, with
Qualifications
- PhD in relevant field with 2+ years, MS with 11+ years, or BS with 12+ years of experience.
- Experience in biotherapeutics drug product process development and protein chemistry.
- Familiar with cGMP, QA expectations, and data-driven development.
Responsibilities
- Lead drug product development teams with cross-functional stakeholders.
- Design and execute development studies and support tech transfer actions.
- Prioritize tasks and guide project teams including junior members.
- Analyze data and author technical reports for regulatory filings.
- Keep current with literature on drug product manufacturing and single-use systems.
- Present findings to internal and external stakeholders; prepare presentations.
Skills
Education
Tools
Job description
AstraZeneca plc in New Haven seeks a Senior Scientist to lead research, design and execute studies for drug product process development of parenteral biologics. You will oversee DS/DP unit operations including freeze/thaw, sterile filling, filtration, visual inspection and related QC support, with hands-on biotherapeutics development experience.
The role emphasizes technology transfer, deviations and change control support, data analysis, and preparation of reports for regulatory filings, with
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