Development Scientist I, Analytical Development and Quality Control

Alexion • New Haven, CT

11h • Onsite

About The Position

This role focuses on the analytical characterization of biotherapeutics from clinical through commercial stages, with a strong emphasis on antibodies, proteins, and peptides. The work involves applying a range of analytical techniques for size and charge variant analysis, and interpreting protein post-translational modifications and their impact on biological function. A key expectation is the ability to independently design and generate procedures, protocols, and reports for protein forced degradation studies, fractionation studies, comparability assessments, and critical quality attribute (CQA) evaluations. Additional responsibilities may include representing the group on cross-functional development teams, as well as training and leading elected day-to-day activities of junior scientists. Ready to see how deep scientific rigor can directly influence patient outcomes? Accountabilities In this position, the Development Scientist I will perform enrichment, fractionation, and detailed characterization of protein variants, including charge and size variants, to support biotherapeutic development. The role includes designing and conducting experimental studies, developing and optimizing analytical methods, and delivering comparability and forced degradation studies that inform product understanding and control strategies. The scientist will summarize structure–function relationship findings and author CQA reports that guide decision-making across development stages. Responsibilities extend to active participation in cross-functional development teams, representing the Protein Characterization group, and leading scientific and technical problem-solving efforts within the team. The role also includes authoring CMC sections for regulatory submissions, technical reports, department-specific protocols and reports, and general operating procedures, while driving the development and implementation of new procedures and work practices that improve analytical capabilities. How will your insights shape the next generation of rare disease therapies?

Requirements

• BS degree with 8+ years, MS degree with 6+ years, or Ph.D. degree with 0 to 2 years in Chemistry, Biochemistry, or related field of Industry experience
• Experienced in separations science (e.g., SEC, RP, IEX, HIC, CE-SDS and cIEF).
• Experienced in protein size and charge variants identification and product quality attribute severity assessment.
• Planning and organizing skills to plan, implement, and track commitments of the laboratory and to adjust to changing priorities.
• High emotional intelligence, excellent people skills, and effective communication skills.

Nice To Haves

• Experience in characterization of various biologic modalities (e.g., mAb, multi-specifics, fusion protein, enzyme).
• Experience in CMC development activities, including analytical, DS upstream and downstream, formulation and DP activities.

Responsibilities

• Perform enrichment, fractionation, and detailed characterization of protein variants, including charge and size variants, to support biotherapeutic development.
• Design and conduct experimental studies.
• Develop and optimize analytical methods.
• Deliver comparability and forced degradation studies that inform product understanding and control strategies.
• Summarize structure–function relationship findings and author CQA reports that guide decision-making across development stages.
• Actively participate in cross-functional development teams, representing the Protein Characterization group.
• Lead scientific and technical problem-solving efforts within the team.
• Author CMC sections for regulatory submissions, technical reports, department-specific protocols and reports, and general operating procedures.
• Drive the development and implementation of new procedures and work practices that improve analytical capabilities.
• Train and lead elected day-to-day activities of junior scientists.

Benefits

• The environment combines the agility of a biotech with the reach and resources of a global organization, offering room to grow skills, explore new ideas, and see the impact of rigorous analytical science on therapies that address profound unmet needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level