Development Scientist II: Analytical QC & LIR Lead

Alexion Pharma Spain S.L.; New Haven, Northern (CT, KY); Hybrid; USD 85,000 - 125,000; Full time

Job summary

Alexion Pharma Spain S.L. is seeking a Development Scientist II in New Haven, CT, to join the External Analytical Development and Quality Control (ADQC) group. You will own laboratory investigations (LIRs) and coordinate with CROs to ensure timely, compliant release testing and CoA generation.

The role requires strong analytical skills, attention to detail, and collaboration with QA, Compliance, and development teams. A Ph.D. or M.S. with extensive pharma experience is preferred.

Qualifications

• Advanced degree in Biochemistry or Chemistry with lab experience in pharma.
• Experience in analytical development for biologics and external QC.
• Knowledge of cGMP, FDA, ICH guidelines; strong documentation practices.

Responsibilities

• Lead LIR investigations and manage CRO collaborations.
• Develop and qualify analytical assays for release testing.
• Ensure timely, compliant lab documentation and data integrity.

Skills

Assay Development

Cell Culture

Biochemistry

Flow Cytometry

Biology

ELISA

Microscopy

Drug Discovery Process

Education

Advanced degree in Biochemistry or Chemistry

Tools

Veeva Vault

LIMS

ValGenesis

Kneat

JMP

Tableau

SAS

SharePoint/BOX

Job description

Alexion Pharma Spain S.L. is seeking a Development Scientist II in New Haven, CT, to join the External Analytical Development and Quality Control (ADQC) group. You will own laboratory investigations (LIRs) and coordinate with CROs to ensure timely, compliant release testing and CoA generation.

The role requires strong analytical skills, attention to detail, and collaboration with QA, Compliance, and development teams. A Ph.D. or M.S. with extensive pharma experience is preferred.