AstraZeneca
Development Scientist I, Analytical Development and Quality Control
US - New Haven - CT · Junior
Sponsorship not specifiedDetected 1 day ago
ExcelGMPResearchProtein AnalysisCommunicationProblem SolvingMicrosoft Office
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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- In addition, this position is expected to interact regularly with scientific staff in other Research & Development groups as well as Manufacturing, Quality Assurance and Quality Control groups.
- If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
Responsibilities
- Design and optimization of platform workflows compliant with ICH Q14
- Working with various Research and Development teams to support transfer of analytical test methods for development and clinical support.
- Developing workflows compliant with ICH Q14 and amenable to ICH Q2 (R2) requirements
- Identifying ways of utilizing AI tools to build a robust database for predicting platform fit potential of new molecules in compliance with ICH Q14 risk assessment guidelines
- Supporting CMC teams and potentially serving as analytical lead
Requirements
- This position will also support other analytical method development related to characterization and investigation efforts, as well as conduct testing for Alexion's biotherapeutic products when required.
- Participation in method validation and transfer or troubleshooting of methods to internal and external laboratories may be required.
- Experience with assay development, optimization, qualification, and validation for protein therapeutics.
- As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted
Nice to have
- Organizing activities of self and others as well as supervise operation, maintenance and troubleshooting of analytical instrumentation (e.g., Revvity LabChip, Protein Simple iCE3, MauriCE, and ProteoAnalyzer)
- Supporting application of new cutting-edge technologies to improve throughput and enhance capability of cGMP testing.
- Authoring SOPs, study plans, protocols, and method development reports.
- Draft reports for regulatory filing
- Serve as CE subject matter expert on analytical sub-teams.
- Maintaining knowledge of current scientific principles and theories.
- Train other lab personnel as assigned in areas of expertise and participate in cross-functional process development teams.
- Seeking out and evaluating new instruments, methods, techniques, and technology platforms to enhance analytical operations
Benefits
- The position may require working as part of a CMC team and advocating on behalf of Analytical Development and Quality Control, responding to health authority queries, and coordinating in-country testing requirements.
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This listing is sourced directly from AstraZeneca's careers page and normalized into a canonical job model.