Spyre Therapeutics - Senior Scientist, Translational Science
Requirements
• 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 bioanalysis and drug development in the biotechnology or pharmaceutical industry.. • 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, 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.
Responsibilities
• Manage the day-to-day execution of outsourced bioanalytical activities for pharmacokinetic, immunogenicity, and/or biomarker assays conducted at 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.
Benefits
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture of our young company, wear multiple hats, and learn quickly. • Market-competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. • Two, one-week company-wide shutdowns each year. • Commitment to growing you professionally and providing access to resources to further your development. • 100% remote team with frequent in-person meetings to build relationships and problem solve. • The expected salary range offer for this role is $160,000 to $202,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.
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