Analytical Development Scientist – Late-Stage QC & Transfer

BioCT; New Haven (CT); Hybrid; USD 120,000 - 190,000; Full time

Job summary

AstraZeneca is seeking a highly skilled scientist to lead late-stage analytical development for biologics. The role focuses on method validation, transfer, and lifecycle management across clinical and commercial programs, with hands-on troubleshooting and data interpretation to ensure robust, phase-appropriate assays.

You will collaborate with PDCS, Regulatory, QA, and external labs to support regulatory submissions and inspections, guiding cross-functional teams through OOS/OOT investigations

Qualifications

• PhD or MSc in Biochemistry, Analytical Chemistry, Molecular Biology, Pharmaceutical Sciences, or related field.
• 1+ years of progressive biologics analytical development experience.
• Hands-on technical and strategic experience with biologic modalities (mAbs, bispecifics, fusion proteins).
• Experience with method validation/qualification and transfer activities.

Responsibilities

• Lead analytical method validation, transfer, and compendial method verification across clinical development and lifecycle stages.
• Develop strategies for method validation, verification, transfer, and lifecycle management.
• Oversee cross-functional assay troubleshooting and OOS/OOT investigations during validation and transfer.
• Design investigation plans and execute lab experiments to identify root causes and solutions.
• Review testing results, specify performance metrics, and prepare regulatory documentation.

Skills

Biologics analytics

Analytical development

GxP

Data interpretation

Education

PhD or MSc in Biochemistry/Analytical Chemistry/Molecular Biology/Pharmaceutical Sciences

Tools

JMP

Empower

SoftMax

Job description

AstraZeneca is seeking a highly skilled scientist to lead late-stage analytical development for biologics. The role focuses on method validation, transfer, and lifecycle management across clinical and commercial programs, with hands-on troubleshooting and data interpretation to ensure robust, phase-appropriate assays.

You will collaborate with PDCS, Regulatory, QA, and external labs to support regulatory submissions and inspections, guiding cross-functional teams through OOS/OOT investigations