Senior Scientist — Late-Stage Analytical Development & QC

Alexion Pharma Spain S.L.; New Haven, Northern (CT, KY); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Alexion, part of AstraZeneca, seeks a Scientist III to lead analytical development and clinical QC in New Haven. You will guide end-to-end analytical strategy for late-stage biologics, supervise method validations, transfers, and QC testing while coordinating with PDCS, Regulatory, QA, and external labs.

Ideal candidates have a PhD or MSc in a relevant field and 4+ years in biologics analytics, with strong ICH, USP/EP knowledge and experience in developing and qualifying assays across Phase 3 to

Qualifications

• Advanced degree with success in biologics analytical development.
• Experience with method development, transfer, and lifecycle management.

Responsibilities

• Lead analytical method validations, transfers across clinical and commercial stages.
• Author regulatory submissions and respond to health authority inquiries.

Skills

Analytical development

Method validation

Transfer to QC/CMOs

ICH Q2 experience

GxP documentation

Cross-functional leadership

Education

PhD in Biochemistry

Tools

Chromatography

CE-SDS

cIEF

Job description

Alexion, part of AstraZeneca, seeks a Scientist III to lead analytical development and clinical QC in New Haven. You will guide end-to-end analytical strategy for late-stage biologics, supervise method validations, transfers, and QC testing while coordinating with PDCS, Regulatory, QA, and external labs.

Ideal candidates have a PhD or MSc in a relevant field and 4+ years in biologics analytics, with strong ICH, USP/EP knowledge and experience in developing and qualifying assays across Phase 3 to