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Spyre Therapeutics
Spyre Therapeutics
11 – 50 Employees
ConsultingHealthcareManufacturing
Spyre Therapeutics is a biopharmaceutical company developing antibody-based therapies for inflammatory bowel disease (IBD). Its research focuses on precision immunology, best-in-class antibodies, and rational treatment combinations designed to improve efficacy and convenience for patients. The company brings together an experienced team with backgrounds in developing and commercializing therapies across multiple diseases, supported by a collaborative approach to advancing new IBD treatment options.
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Senior Scientist, Translational Science (Remote - United States)

Lead outsourced pharmacokinetic, immunogenicity, and biomarker assay programs for Spyre Therapeutics, an immunology-focused biotechnology company. Coordinate CROs, clinical sample testing, and regulatory bioanalytical deliverables.

USUnited States
$160,000 – $202,000 / year
RemoteFull-timeSeniorEnglish RequiredTranslator

Description

  • Oversee daily outsourced bioanalytical work for pharmacokinetic, immunogenicity, and biomarker assays performed by contract research organizations.
  • Guide the design, development, qualification, validation, implementation, and maintenance of bioanalytical methods in line with regulatory guidance and industry standards.
  • Assess assay protocols, validation documentation, sample analysis plans, reports, and bioanalytical data packages for scientific rigor, completeness, and data integrity.
  • Partner with CROs and internal teams to monitor milestones, communicate risks, and ensure timely delivery of scopes, quotes, contracts, purchase orders, samples, and reagents.
  • Coordinate clinical sample analysis across studies, including sample availability, testing priorities, laboratory schedules, and data delivery.
  • Collaborate with internal and external subject matter experts to investigate and resolve assay development, validation, and clinical analysis issues.
  • Interpret bioanalytical data, trends, and anomalies; develop conclusions and communicate findings to the Translational Science team.
  • Provide bioanalytical content for laboratory manuals and data transfer agreements.
  • Perform additional duties as assigned.

Requirements

  • PhD in biology, biochemistry, pharmacology, chemistry, or a related scientific field plus at least two years of relevant industry experience, or an MS plus at least five years of relevant experience in regulated bioanalysis and biotechnology or pharmaceutical drug development.
  • Experience supporting large-molecule pharmacokinetic and immunogenicity assays, including neutralizing antibody methods.
  • Working knowledge of several bioanalytical platforms, including LC-MS/MS, ELISA, electrochemiluminescence, ligand-binding assays, MSD, and multiplex assays.
  • Experience managing CRO relationships and reviewing technical documents, data, reports, and study deliverables.
  • Understanding of GLP, GCLP, data integrity principles, and applicable bioanalytical and immunogenicity regulatory expectations.
  • Experience authoring or reviewing bioanalytical reports and contributing scientific material to regulatory submissions.
  • Strong written and verbal communication, scientific judgment, and ability to explain technical information to diverse audiences.
  • Highly organized, collaborative, and detail-oriented, with strong prioritization and time-management skills in a fast-paced environment.

Benefits

  • Competitive compensation and benefits package with performance bonuses, equity grant opportunities, health and welfare coverage, and retirement benefits.
  • Unlimited paid time off.
  • Two company-wide shutdowns of one week each year.
  • Professional growth support and access to development resources.
  • Fully remote team with frequent in-person meetings for relationship building and collaborative problem-solving.
  • Work in a fast-moving, dynamic environment with opportunities to shape company culture, take on varied responsibilities, and learn quickly.

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