Development Scientist II: External QC & Investigations (GMP)

Alexion Pharmaceuticals, Inc.; New Haven (CT); On-site; USD 95,000 - 140,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. is seeking a Development Scientist II to join the External Analytical Development and Quality Control group in New Haven.

This role drives high-quality, compliant external QC testing with ownership of laboratory investigations through external contract laboratories and change controls related to ADQC biologic programs. You will partner with QA, Compliance, Analytical Development and Stability teams to ensure timely LIR closures and generation of final release CoAs

Qualifications

• Experience leading lab investigations (LIRs) and CAPAs in pharma or biotech.
• Strong accuracy in documentation and data review.
• Knowledge of cGMP, FDA regulations, ICH guidelines and EU regulations.

Responsibilities

• Generate and own LIRs for OOS, OOT, and atypical results with root-cause analysis and CAPAs.
• Design investigational testing plans for compliant closure of investigations.
• Lead cross-functional meetings with QA to align investigations.
• Create plans, track, and present timelines to meet targets.
• Review analytical data to ensure assay performance.
• Identify opportunities to improve systems for cGMP compliance.
• Demonstrate strong presentation skills.

Skills

Analytical thinking

Problem solving

Documentation accuracy

Cross-functional collaboration

MS Word

MS Excel

MS PowerPoint

cGMP knowledge

Regulatory compliance

Communication skills

Education

Advanced degree in Biochemistry, Chemistry or related

Tools

Veeva Vault

LIMS

ValGenesis

Kneat

JMP

Tableau

SAS

Job description

Alexion Pharmaceuticals, Inc. is seeking a Development Scientist II to join the External Analytical Development and Quality Control group in New Haven.

This role drives high-quality, compliant external QC testing with ownership of laboratory investigations through external contract laboratories and change controls related to ADQC biologic programs. You will partner with QA, Compliance, Analytical Development and Stability teams to ensure timely LIR closures and generation of final release CoAs