Biologics Analytics Scientist — Method Dev & Validation

Alexion

Blanchardstown

On-site

EUR 65,000 - 90,000

Full time

3 days ago
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Job summary

AstraZeneca is seeking a biologics-focused analytical scientist to design, validate, and transfer robust analytical methods that enable reliable product characterization and release. Based in the College Park labs, you will collaborate across manufacturing, development, quality, and regulatory functions to underpin investigations, decision-making, and data integrity.

From day one, you will contribute to method development, troubleshooting, and process optimization in a fast-paced, regulatory

Qualifications

  • Bachelor’s degree in biochemistry, chemistry, microbiology or a relevant scientific discipline.
  • Experience in bio/pharma manufacturing or development.
  • Hands-on experience with bio-analytical techniques for biologicals.
  • Proven knowledge of cGMP/GLP requirements and standard methodologies.

Responsibilities

  • Develop and refine analytical methods for biologics to improve specificity, sensitivity, and throughput.
  • Lead method qualification, validation/co-validation, and transfer across laboratories and sites.
  • Perform capability analyses and data trending to establish control strategies.
  • Design and execute studies; analyze data and produce clear, defensible reports.

Skills

Bio-analytical techniques
cGMP/GLP knowledge
Data integrity and problem solving
Regulatory compliance awareness

Education

Bachelor’s degree in biochemistry, chemistry, microbiology or relevant science
Master’s or PhD desirable

Tools

LIMS/ELN systems
JMP/Minitab (statistical tools)
HPLC/UPLC, CE-SDS, icIEF/cIEF, ELISA, qPCR, LC-MS

Job description

AstraZeneca is seeking a biologics-focused analytical scientist to design, validate, and transfer robust analytical methods that enable reliable product characterization and release. Based in the College Park labs, you will collaborate across manufacturing, development, quality, and regulatory functions to underpin investigations, decision-making, and data integrity.

From day one, you will contribute to method development, troubleshooting, and process optimization in a fast-paced, regulatory

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