Associate Director, Late-Stage Analytics & QC Strategy

Alexion Pharmaceuticals, Inc.; New Haven (CT); On-site; USD 100,000 - 150,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. in New Haven, Connecticut is seeking a leader for their Late Stage Analytical team. This role involves overseeing analytical method validation and development, authoring regulatory submissions, and collaborating across teams to ensure project success. Candidates should have an advanced degree and significant experience in biologics analytical development. Expect a dynamic workplace that balances in-office collaboration with individual flexibility.

Qualifications

• 8–12+ years of progressive experience in biologics analytical development.
• Validated expert knowledge in method development, qualification, and validation.
• Strong command of ICH guidelines and compliance expectations for biologics.

Responsibilities

• Lead analytical method validation and transfers across clinical development stages.
• Oversee QC testing and maintain the health of the analytic program.
• Author regulatory documents for submissions to health authorities.

Skills

Analytical expertise

Management of development projects

Technical proficiency with monoclonal antibodies

Expertise in chromatography

Strong written communication skills

Problem-solving abilities

Education

PhD or MSc in Biochemistry, Analytical Chemistry, or related field

Tools

Chromatography Data Systems

Statistical software (e.g., JMP)

Job description

Alexion Pharmaceuticals, Inc. in New Haven, Connecticut is seeking a leader for their Late Stage Analytical team. This role involves overseeing analytical method validation and development, authoring regulatory submissions, and collaborating across teams to ensure project success. Candidates should have an advanced degree and significant experience in biologics analytical development. Expect a dynamic workplace that balances in-office collaboration with individual flexibility.