Senior Scientist, Translational Science

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $160k - $202k / year

⏰ Full Time

🟠 Senior

🌎 Translator / Interpreter

👻 Ghost score 0%

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Spyre Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Spyre Therapeutics is a biopharmaceutical company focused on developing therapies for Inflammatory Bowel Disease (IBD). The company is committed to creating best-in-class antibodies, rational therapeutic combinations, and employing precision immunology approaches to enhance treatment efficacy and convenience for IBD patients. With a team experienced in developing and commercializing treatments across various diseases, Spyre Therapeutics is dedicated to improving treatment options and outcomes for patients through advanced research in immunology. The company fosters a collaborative and innovative environment to achieve its mission of providing promising new treatment options for IBD.

📋 Description

• 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 during assay development, validation, or clinical sample analysis • Evaluate bioanalytical data, trends, and anomalies; summarize conclusions and communicate results within the translation science team • Contribute bioanalytical content to laboratory manuals and data transfer agreements • Other duties as assigned

🎯 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

🏖️ Benefits

• Market-competitive compensation and benefits package, including 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 • 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