Scientist III, Analytical Development and Clinical Quality Control

Alexion Pharmaceuticals - New Haven, CT

Full-time - Senior

New Haven, CT

Chemical Manufacturing

About the position

As a Scientist III in the Late Stage Analytical team at Alexion, AstraZeneca, you will manage development projects throughout the CMC lifecycle, focusing on late-stage analytical activities. This role requires strong analytical experience and the ability to handle multiple projects simultaneously while collaborating with various teams including Regulatory, QA, and QC laboratories. You will lead the analytical team from pre-clinical stages through product launch, authoring regulatory filings, and ensuring compliance with industry standards.

Responsibilities

• Interact with cross-functional teams to lead analytical activities.
• Lead method transfer and validation activities.
• Drive communications with collaborators and stakeholders.
• Lead troubleshooting and investigations for OOS/OOT results.
• Review analytical testing procedures and provide subject matter expertise for regulatory interactions.
• Lead all analytical late-stage activities as the analytical functional lead for clinical CMC programs.

Requirements

• MS degree in Biochemistry or related field with 10+ years of industry experience, or Ph.D. degree in Biochemistry or related field with 6+ years of industry experience.
• Experience in CMC structure and previous project lead experience for analytical functions.
• Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein).
• Extensive experience in separations science (e.g., SEC, RP, IEX).
• Experience in molecular biology (PCR, DNA extraction) and immunoassay (ELISA) techniques.
• Experience in microbiology assays (e.g., bioburden, endotoxin, sterility, CCIT).
• Strong background in analytical methodologies and understanding of Critical Quality Attributes/QbD/DOE principles.
• Ability to develop and design experiments independently and critically evaluate data.
• Experience in testing strategy for late-stage programs in preparation for BLA filing.
• Excellent written skills for drafting GMP-related documents.
• Experience authoring regulatory filings and responses.
• Excellent collaboration skills and experience working in cross-functional teams.

Nice-to-haves

• Extensive experience in compendia methods and multi-country compendia requirements (USP, EP, JP).
• Strong direct experience in the development, validation, and transfer of analytical methods for biological products in a cGMP environment.

Benefits

• Flexible working arrangements with a minimum of four days in the office per week.
• Commitment to diversity, equity, and inclusion in the workplace.