Late-Stage Analytical Development & CMC Lead (Biologics)

AstraZeneca; New Haven (CT); On-site; USD 180,000 - 230,000; Full time

Job summary

Alexion, now part of AstraZeneca, seeks a senior analytical leader to drive late-stage strategy across CMC programs including method transfer/validation and regulatory submissions. You will lead cross-functional teams, oversee QC testing, and author CTD modules and responses to health authorities.

The role emphasizes strong technical expertise in chromatography, bioassays, and compendia compliance (USP/EP/JP) and requires proven experience managing development projects through the biologics

Qualifications

• Advanced degree with 8–12+ years in biologics analytical development across clinical and commercial stages.
• Experts in monoclonal antibodies, bispecifics, fusion proteins, with strong chromatography and bioassay skills.
• Experience with USP/EP/JP compendia and ICH Q2-compliant method development.

Responsibilities

• Lead analytical method validation, transfers, and compendia verifications across stages.
• Serve as analytical lead for CMC programs with cross-functional collaboration.
• Own end-to-end strategy for late-stage biologics, including control strategy and QC testing supervision.
• Oversee analytical QC testing, data analysis, and risk identification in the CMC program.
• Lead regulatory authoring for CTD modules and respond to health authority queries.

Skills

Analytical leadership

Regulatory writing

CMC strategy

Method transfer/validation

GxP documentation

ALCOA+ data integrity

ICH Q2 knowledge

Chromatography

QA/CMO collaboration

Team mentorship

Education

PhD in Biochemistry or related field

Tools

LIMS

ELN

Chromatography Data Systems

JMP (stats software)

Job description

Alexion, now part of AstraZeneca, seeks a senior analytical leader to drive late-stage strategy across CMC programs including method transfer/validation and regulatory submissions. You will lead cross-functional teams, oversee QC testing, and author CTD modules and responses to health authorities.

The role emphasizes strong technical expertise in chromatography, bioassays, and compendia compliance (USP/EP/JP) and requires proven experience managing development projects through the biologics