Biologics Analytical Scientist — Method Dev & Validation

AstraZeneca plc; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

AstraZeneca plc is seeking a scientifically rigorous analyst to advance analytical methods for biologics in a regulatory-focused environment. Based in our College Park labs, you will collaborate across manufacturing, development, quality, and regulatory units to design, validate, and transfer robust analytical procedures that support product release and investigations.

You will contribute to method development, qualification, and lifecycle management, while upholding data integrity and

Qualifications

• Minimum BSc in biochemistry, chemistry, microbiology or a relevant scientific discipline.
• Experience in (bio)pharmaceutical manufacturing or development.
• Hands-on bio-analytical techniques for biologicals.
• Knowledge of cGMP/GLP and standard methodologies.

Responsibilities

• Develop and refine analytical methods for biologics to improve specificity, sensitivity, and throughput.
• Lead method qualification, validation, and transfer across sites.
• Perform capability analyses and data trending to establish control strategies.
• Design protocols and execute studies; report findings clearly.

Skills

Bioanalytical experience

Analytical methodologies

cGMP/GLP knowledge

Problem solving

Team collaboration

Education

Bachelor’s degree in biochemistry/chemistry/ microbiology

Tools

JMP

Minitab

LIMS/ELN systems

Job description

AstraZeneca plc is seeking a scientifically rigorous analyst to advance analytical methods for biologics in a regulatory-focused environment. Based in our College Park labs, you will collaborate across manufacturing, development, quality, and regulatory units to design, validate, and transfer robust analytical procedures that support product release and investigations.

You will contribute to method development, qualification, and lifecycle management, while upholding data integrity and