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. This role will contribute to assay development, qualification, validation, sample analysis, data interpretation, and reporting across multiple analytical platforms at Contract Research Organizations (CROs). The Senior Scientist will serve as a scientific point of contact for CROs, communicate plans and progress within the translation sciences team, and help ensure that all activities are conducted in accordance with applicable regulatory requirements, company procedures, and program timelines. 

Key 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.  

Ideal Candidate 

• 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. 

 What We Offer 

• 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. 

• Unlimited PTO 

• 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. 

 As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. s.