Late-Stage Analytical Scientist: Validation & Transfer

Alexion; New Haven (CT); On-site; USD 120,000 - 190,000; Full time

Job summary

AstraZeneca plc is seeking an experienced Biologics Analytical Scientist to advance late-stage biologics from Phase 3 through commercialization. You will lead analytical method validation, transfer, and lifecycle activities, working with cross-functional teams to ensure robust, compliant methods across clinical and commercial programs.

The role requires deep technical expertise in analytical technologies, regulatory alignment, and a collaborative approach to solving complex challenges in a

Qualifications

• PhD or MSc in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or related field.
• 1+ years of progressive experience in biologics analytical development.
• Experience with biologic modalities such as mAbs, bispecifics, fusion proteins.

Responsibilities

• Lead analytical method validation, transfer, and compendial verification across clinical and late-stage programs.
• Develop strategies for validation, verification, transfer, and lifecycle management.
• Lead cross-functional teams in troubleshooting and OOS/OOT investigations during validation/transfer.
• Design investigation plans and execute experiments to identify root causes and solutions.
• Review analytical test procedures, method performance, and testing results for global networks.
• Provide input on gap assessments and remediation strategies post-validation/transfer.
• Author/review validation and transfer protocols and reports for late-stage programs.
• Provide SME support for regulatory submissions, agency interactions, and inspections.
• Serve as analytical lead or team member for CMC programs, especially late-stage.
• Collaborate with internal teams and external labs to ensure robust, compliant methods.

Skills

Biologics analytics

Method validation/transfer

OOS/OOT investigations

GxP/regulatory knowledge

Data analysis software

Project leadership

Education

PhD in Biochemistry/Analytical Chemistry/related

MSc in Biochemistry/Analytical Chemistry/related

Tools

JMP

Empower

SoftMax

LIMS

ELN

Job description

AstraZeneca plc is seeking an experienced Biologics Analytical Scientist to advance late-stage biologics from Phase 3 through commercialization. You will lead analytical method validation, transfer, and lifecycle activities, working with cross-functional teams to ensure robust, compliant methods across clinical and commercial programs.

The role requires deep technical expertise in analytical technologies, regulatory alignment, and a collaborative approach to solving complex challenges in a