Analytical Development Scientist II – QC & Investigations

Alexion Pharma Spain S.L.; New Haven (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

Alexion Pharma Spain S.L. is seeking a Development Scientist II to join the External Analytical Development and Quality Control (ADQC) group. You will own laboratory investigations (LIRs) with external contract labs, drive CAPAs, and ensure timely closure to enable final release CoAs for patient care.

The role requires designing testing plans, leading QA meetings, and delivering compliant, high-quality investigative outcomes within the cGMP framework. A Ph.D. or M.S.

Qualifications

• Strong analytical and problem-solving skills with the ability to conduct risk assessments and root cause analysis.
• Broad knowledge of pharmaceutical QA, regulatory compliance, cGMP, FDA regulations, ICH guidelines, and EU regulations.
• Excellent written and verbal communication; effective cross-functional collaboration.
• Proficiency with MS Word, Excel, PowerPoint and document control systems.
• Willingness to travel up to 10% as needed.

Responsibilities

• Generate, mirror, review and drive ownership of LIRs to close OOS/OOT/Atypical results with structured root cause analysis and CAPAs.
• Design investigational testing plans to ensure compliant closure of investigations within the quality system.
• Lead cross-functional meetings with QA to align on investigations and actions.
• Create project plans, track timelines and present progress to meet targets.
• Review analytical data to verify assay performance and data integrity.
• Identify opportunities to improve systems for cGMP compliance and quality.
• Demonstrate strong presentation skills in communicating findings and plans.

Skills

Analytical thinking

Problem solving

Attention to detail

Communication skills

Presentation skills

Cross-functional collaboration

Willingness to travel

Education

M.S. or Ph.D. in Biochemistry or Chemistry or related

Tools

Veeva Vault

LIMS

ValGenesis

Kneat

JMP

Tableau

SAS

Microsoft SharePoint

BOX

MS Office

Job description

Alexion Pharma Spain S.L. is seeking a Development Scientist II to join the External Analytical Development and Quality Control (ADQC) group. You will own laboratory investigations (LIRs) with external contract labs, drive CAPAs, and ensure timely closure to enable final release CoAs for patient care.

The role requires designing testing plans, leading QA meetings, and delivering compliant, high-quality investigative outcomes within the cGMP framework. A Ph.D. or M.S.