Senior Scientist, Translational Science

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre’s pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs.

Role Summary

We are seeking a highly skilled and motivated Senior Scientist, Translational Science, to join our growing team. This individual will support the execution of outsourced bioanalytical and biomarker activities for Spyre’s clinical programs, with primary responsibility for pharmacokinetic, immunogenicity, and PD assays.

Key Responsibilities

• Manage the day-to-day execution of outsourced bioanalytical activities for pharmacokinetic, immunogenicity, and/or biomarker assays conducted at Contract Research Organizations (CROs).
• Provide scientific input to the design, development, qualification, validation, implementation, and maintenance of bioanalytical methods in accordance with applicable regulatory guidance and industry practices.
• Review assay protocols, validation plans and reports, sample analysis plans and reports, and bioanalytical data packages for scientific quality, completeness, and data integrity.
• Coordinate with CROs and internal partners to track milestones, communicate risks, and support timely availability of required scopes, quotes, contracts, purchase orders, samples, and reagents.
• Plan and coordinate clinical sample analysis across multiple studies, including sample availability, testing priorities, laboratory timelines, and data delivery.
• Work with internal and external subject matter experts to investigate and resolve issues that arise during assay development, validation, or clinical sample analysis.
• Evaluate bioanalytical data, trends, and anomalies; summarize conclusions and communicate results clearly within the translation science team.
• Contribute bioanalytical content to laboratory manuals and data transfer agreements.
• Other duties as assigned.

Ideal Candidate

• A PhD in biology, biochemistry, pharmacology, chemistry, or a related scientific discipline with 2+ years of relevant industry experience; or an MS with 5+ years of relevant experience in regulated bioanalysis and drug development in the biotechnology or pharmaceutical industry.
• Experience supporting large-molecule pharmacokinetic and immunogenicity assays, including neutralizing antibody methods.
• A working knowledge of multiple bioanalytical platforms, such as LC-MS/MS, ELISA, electrochemiluminescence, ligand-binding assays, MSD, and/or multiplex assays.
• Experience engaging and overseeing CROs, including review of technical documents, data, reports, and study deliverables.
• Knowledge of GLP, GCLP, data integrity principles, and applicable bioanalytical and immunogenicity regulatory expectations.
• Experience writing or reviewing bioanalytical reports and contributing scientific content to regulatory submissions.
• Excellent written and verbal communication skills, sound scientific judgment, and the ability to explain technical information to varied audiences.
• Detail-oriented and collaborative, with strong organizational, prioritization, and time-management skills and the ability to manage multiple activities in a fast-moving environment.