Development Scientist I: Biotherapeutics Method Development

AstraZeneca GmbH; New Haven (CT); Hybrid; USD 90,000 - 120,000; Full time

Job summary

AstraZeneca is seeking a Development Scientist I to advance analytical methods for clinical and commercial biotherapeutics. You will develop and optimize UHPLC/HPLC methods, qualify processes, and support regulatory filings with robust analytical data.

The role involves coordinating instrument maintenance, QA interactions, and cross-functional team collaboration within R&D and manufacturing to ensure high-quality results.

Qualifications

• PhD or MS in Chemistry/Biochemistry or related biological science with 2+ years industry experience.
• Experience in UHPLC/HPLC method development for protein therapeutics is required.
• Ability to solve problems independently with a scientific approach.

Responsibilities

• Develop and optimize UHPLC/HPLC methods for quality attributes of therapeutic proteins (SEC, RP-HPLC, IEX, HIC).
• Supervise and maintain analytical instrumentation (UPLC/HPLC, detectors such as UV, FLR, ELSD, CAD, RI, MALS).
• Support application of new technologies to improve throughput for cGMP testing.
• Draft SOPs, METs, study plans, and method development/qualification reports for regulatory filing.

Skills

UHPLC

Method development

Protein therapeutics

cGMP testing

Data integrity

Regulatory submissions

Education

PhD/MS in Chemistry

Tools

Empower

UPLC/HPLC

Chromatography

Job description

AstraZeneca is seeking a Development Scientist I to advance analytical methods for clinical and commercial biotherapeutics. You will develop and optimize UHPLC/HPLC methods, qualify processes, and support regulatory filings with robust analytical data.

The role involves coordinating instrument maintenance, QA interactions, and cross-functional team collaboration within R&D and manufacturing to ensure high-quality results.