Senior Analytical Scientist, Late-Stage Biologics

AstraZeneca GmbH; New Haven, Northern (CT, KY); Hybrid; USD 110,000 - 170,000; Full time

Benefits offered by this job

Office flexibility

Onsite collaboration

Job summary

AstraZeneca GmbH is seeking an experienced Scientist II in Analytical Development and Clinical QC to drive late-stage analytical strategies, method transfer and validation, and regulatory submissions. You will lead cross-functional teams across PDCS, Regulatory, QA, and external laboratories to ensure QbD-aligned control strategies from Phase 3 through commercialization.

The role requires an advanced degree and 4+ years in biologics analytics, with hands-on expertise in chromatography, CE,

Qualifications

• Advanced degree in Biochemistry/Analytical Chemistry or a related field.
• 4+ years of progressive experience in biologics analytical development across clinical and commercial stages.
• Proven hands-on strategic and technical expertise with monoclonal antibodies, bispecifics, and fusion proteins.

Responsibilities

• Lead analytical method validations, transfers, and compendia method verifications across clinical development.
• Serve as analytical lead for CMC programs, focusing on late-stage programs.
• Develop and implement end-to-end analytical strategy for late-stage biologics programs.
• Author regulatory submissions and respond to health authority queries.

Skills

Analytical development

Biologics

Regulatory submissions

ICH Q2

GxP documentation

Data analysis

Leadership

Cross-functional collaboration

Education

PhD or MSc in Biochemistry/Analytical Chemistry or related

Tools

LIMS

Chromatography (SEC RP IEX)

Capillary electrophoresis

CTD/IND/MAA writing

ELN / data systems

Job description

AstraZeneca GmbH is seeking an experienced Scientist II in Analytical Development and Clinical QC to drive late-stage analytical strategies, method transfer and validation, and regulatory submissions. You will lead cross-functional teams across PDCS, Regulatory, QA, and external laboratories to ensure QbD-aligned control strategies from Phase 3 through commercialization.

The role requires an advanced degree and 4+ years in biologics analytics, with hands-on expertise in chromatography, CE,