Associate Scientist IV, Biomarker Development

Associate Scientist IV, Biomarker Development Introduction to role

This is a lab-based position, and the role requires the candidate to be present onsite in New Haven, CT. The candidate will follow the science by working in Alexion’s state‑of‑the‑art laboratories to help drive innovation and advance medicine to help improve patient lives. This position offers a unique opportunity to work in a dynamic and innovative research environment developing your career at the interface of research and clinical development.

Contribute to Alexion’s research and clinical development programs through the identification of suitable biomarkers for preclinical and clinical development of therapeutics, development of innovative platforms and omics technology for biomarker discovery and implementing AI systems to accelerate work streams and precision medicine. Perform experiments at the bench to develop, optimize, and validate biomarker assays for monitoring disease pathogenesis and response to therapeutic treatment.

Collaborate with external vendors and cross‑functional teams including discovery, translational research, bio‑analytics, diagnostics and data sciences to drive successful rare‑disease drug development programs.

• Actively contribute to the biomarker support of multiple programs in multiple therapeutic areas through literature reviews and database searches to identify potential new biomarkers of disease activity and/or therapeutic efficacy (mechanism of disease, response/pharmacodynamic, predictive, exploratory, etc).

• Collaborate with colleagues and independently evaluate new technologies, design, develop, troubleshoot novel sample testing protocols, and follow existing protocols for the detection, quantitation and/or functional activity of target biomarkers in complex biological matrices including proteins and nucleic acids.

• Develop and perform in vitro binding or functional assays using purified reagents, primary cells or cell lines (human, murine and/or primate) to evaluate target levels, functional activity or mechanism of action of candidate therapeutics.

• Lead or support biomarker assay validation for clinical sample analysis and interact with cross‑functional sub‑teams and CROs supporting technical, operational and troubleshooting aspects of assays.

• Provide support as required to other Translational Biomarker Research team members and groups within Research.

• Analyze, summarize and present data in individual, group meetings, conferences or in written summary documents.

• All candidates must have 5+ years of pharmaceutical industry experience. In addition, all candidates must have either a BA/BS in biochemistry or related field with 10+ years of total experience or a MS in biochemistry or related field with 7+ years of total experience.

• Solid understanding of the principles of cell biology, disease pathogenesis and strategies for therapeutic intervention and application of these principles for understanding cellular responses and disease pathogenesis.

• Proven track record of technical proficiency, creativity in experimental design and independent, critical thinking to identify novel methods or solutions/troubleshooting.

• Ability to independently design, execute, analyze, and interpret experiments, as well as troubleshoot to overcome technical challenges in a high‑tech, fast‑paced environment.

• Familiarity with clinical stage development programs, protocols, sample handling, data analysis and management according to GCPs.

• Proven experience with protein and cell‑based assays, examples include ELISA, MSD, Luminex, immunoprecipitation, proteomics (e.g., Olink), and/or flow cytometry.

• Hands‑on experience developing and optimizing single and multiplex assays; experience with assay validation in a GxP environment.

• Excellent communication, record keeping and organizational skills and familiarity with electronic lab notebook procedures.

• Strong interpersonal skills and ability to work well with cross‑functional members.

• Experience with Microsoft Office (e.g., Word, Excel, PowerPoint) and data graphing software (e.g., Graphpad Prism) for report writing, presentation and data analysis.