Senior Bioassay Scientist - Analytical Development & QC

AstraZeneca; New Haven (CT); On-site; USD 138,000 - 208,000; Full time

Benefits offered by this job

401(k) retirement plan

Paid vacation and holidays

Health benefits

Job summary

AstraZeneca's Alexion division seeks a Development Scientist III to lead development, qualification, and optimization of bioassay and impurity methods for biotherapeutic candidates, supporting release and stability testing.

You will collaborate cross-functionally with Research, Biologic Drug Substance Development, and QA/QC, draft IND/BLA sections, and contribute to regulatory filings, with travel up to 20% and lab-based duties.

Qualifications

• Ph.D. or master's degree with 6+ years of analytical method development experience in pharma/biotech.
• Experience with method development, qualification, validation, transfer, and investigation for biotherapeutics.
• Willingness to travel up to 20% to support on-site training and troubleshooting.

Responsibilities

• Develop, optimize, and qualify bioassay and impurity methods for therapeutic proteins.
• Lead cross-functional problem-solving and generate SOPs, study plans, and reports.
• Draft IND/BLA sections and respond to health authority queries.

Skills

Flow Cytometry

Biology

ELISA

Cell Culture

Experimental Design

Biochemistry

Chemistry

Biotechnology

Education

Ph.D. or master's in Biochemistry, Molecular and Cellular Biology, Immunology, Chemistry, Bioengineering or related field

Tools

MS Office Suite

JMP

SoftMax Pro

Job description

AstraZeneca's Alexion division seeks a Development Scientist III to lead development, qualification, and optimization of bioassay and impurity methods for biotherapeutic candidates, supporting release and stability testing.

You will collaborate cross-functionally with Research, Biologic Drug Substance Development, and QA/QC, draft IND/BLA sections, and contribute to regulatory filings, with travel up to 20% and lab-based duties.