Biologics Analytical Development Scientist I

Alexion Pharma Spain S.L.; New Haven (CT); On-site; USD 90,000 - 130,000; Full time

Job summary

AstraZeneca in New Haven, CT is seeking a Scientist I in Analytical Development and Clinical QC to lead validation, transfer, and verification of analytical methods across clinical development and lifecycle management. You will collaborate cross-functionally with PDCS, Regulatory, Quality Assurance, and external QC labs to ensure robust, compliant analytical strategies.

You will contribute to regulatory submissions, provide SME input for method validation, and support Phase 3 through

Qualifications

• Advanced degree required in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences or related field.
• Experience validating, transferring, and qualifying analytical methods in biologics or complex modalities.
• Strong writing and communication skills for regulatory submissions and internal reporting.
• Experience with ICH Q2(R2), USP/EP requirements and GxP environments.

Responsibilities

• Lead analytical method validation, transfer, and compendial verification across clinical development and lifecycle stages.
• Develop strategies for method validation, verification, transfer, and lifecycle management.
• Oversee assay troubleshooting and OOS/OOT investigations; design investigation plans and execute experiments.

Skills

Analytical chemistry

Method validation

Cross-functional collaboration

GxP knowledge

Regulatory submissions

Written and verbal communication

Data integrity (ALCOA+

Education

PhD in Biochemistry

MSc in Analytical Chemistry

Tools

JMP

Empower

SoftMax Pro

HPLC/LC-MS data systems

Job description

AstraZeneca in New Haven, CT is seeking a Scientist I in Analytical Development and Clinical QC to lead validation, transfer, and verification of analytical methods across clinical development and lifecycle management. You will collaborate cross-functionally with PDCS, Regulatory, Quality Assurance, and external QC labs to ensure robust, compliant analytical strategies.

You will contribute to regulatory submissions, provide SME input for method validation, and support Phase 3 through