Analytical Development Scientist: CE Methods & QC

Alexion Pharmaceuticals, Inc.; New Haven (CT); On-site; USD 70,000 - 110,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. in the United States is seeking a Development Scientist I to advance release and stability methods for biotherapeutics, including icIEF and CE-based analyses, with collaboration across R&D, Manufacturing, QA, and QC.

You will design, qualify, and transfer analytical methods, support validation, coordinate intra-lab activities, and help respond to health authorities while driving continuous improvement in cGMP testing.

Qualifications

• PhD/MS/Bachelor’s with extensive experience in analytical method development for protein therapeutics.
• Experience with gel and capillary electrophoresis in pharma/biotech is a plus.
• Knowledge of protein characterization for biotherapeutics (mAbs, glycoproteins).
• Experience with assay development, qualification, and validation for protein therapeutics.
• Ability to apply independent, scientific problem-solving to method development.

Responsibilities

• Develop, optimize, and qualify custom capillary electrophoresis methods for quality attributes.
• Supervise operation and troubleshooting of analytical instrumentation (lab equipment list).
• Support transfer of analytical methods and validation protocols within and across labs.
• Draft SOPs, study plans, protocols, and regulatory-oriented reports.
• Collaborate with R&D, Manufacturing, QA, and QC to support cGMP testing.

Skills

Analytical method development

Gel/Capillary electrophoresis

Protein characterization

Assay development

Cross-functional collaboration

Education

PhD in Chemistry/Biochemistry/related

MS in Chemistry/Biochemistry/related

Bachelor’s in related discipline

Tools

Revvity LabChip

Protein Simple iCE3

MauriCE

ProteoAnalyzer

Job description

Alexion Pharmaceuticals, Inc. in the United States is seeking a Development Scientist I to advance release and stability methods for biotherapeutics, including icIEF and CE-based analyses, with collaboration across R&D, Manufacturing, QA, and QC.

You will design, qualify, and transfer analytical methods, support validation, coordinate intra-lab activities, and help respond to health authorities while driving continuous improvement in cGMP testing.