Senior Scientist, Translational Science

The role

This person will support outsourced bioanalytical and biomarker activities for clinical programs. They will manage pharmacokinetic, immunogenicity, and PD assays at Contract Research Organizations.

What you will do

• Manage day-to-day execution of outsourced bioanalytical activities for pharmacokinetic, immunogenicity, and/or biomarker assays at CROs.
• Provide scientific input to the design, development, qualification, validation, implementation, and maintenance of bioanalytical methods.
• Review assay protocols, validation plans, reports, sample analysis plans, and bioanalytical data packages.
• Coordinate with CROs and internal partners to track milestones and support availability of scopes, quotes, contracts, and samples.
• Plan and coordinate clinical sample analysis across multiple studies.
• Work with internal and external subject matter experts to resolve issues during assay development or clinical sample analysis.
• Evaluate bioanalytical data, trends, and anomalies.
• Contribute bioanalytical content to laboratory manuals and data transfer agreements.

Required qualifications

• PhD in biology, biochemistry, pharmacology, chemistry, or a related scientific discipline with 2+ years of relevant industry experience; or MS with 5+ years of relevant experience in regulated bioanal
• Experience supporting large-molecule pharmacokinetic and immunogenicity assays, including neutralizing antibody methods.
• 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.
• Ability to explain technical information to varied audiences.
• Detail-oriented, collaborative, and strong organizational, prioritization, and time-management skills.
• Ability to manage multiple activities in a fast-moving environment.

Benefits

• Market-competitive compensation and benefits package
• Base salary
• Performance bonus
• Equity grant opportunities
• Health, welfare & retirement benefits
• Unlimited PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources for development

About the company

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies in immunology. Their pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F.