Director, Analytical Sciences
Spyre Therapeutics
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $195,000 - $225,000 per year
Job Level
About the role
- Provide strategic and technical leadership for analytical development and quality control activities across the biologics portfolio, including method development, validation, transfer, and lifecycle management, with primary execution through global CDMO partners.
- Serve as a subject‑matter expert for biologics analytical assays and control strategies, contributing to regulatory submissions, driving scientific rigor, assay performance monitoring, and continuous improvement initiatives. Analytical control strategy includes QC methods (SEC, CE, CEX, iCIEF, PMAP, HIC, RP, compendial methods etc) and characterization methods (Fc function assays, mass spectrometry, biophysical-structural, particle characterization, surfactant analysis etc).
- Lead analytical method transfer, qualification, and validation activities at CDMO laboratories, including review and approval of protocols, reports, data packages, and verification of analytical results.
- Ensure analytical activities performed internally and at CDMOs are scientifically rigorous, comply with FDA, cGMP, ICH, and QbD principles, and align with industry best practices and company quality standards and procedures.
- Partner closely with Quality Assurance to establish, maintain, and oversee analytical quality, GMP compliance infrastructure, and inspection readiness for internal and external (CDMO) analytical documents and data.
- Other duties as assigned.
Requirements
- Advanced degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or a related discipline, with 10+ years of biopharma industry experience in analytical development and quality control for protein biologics.
- Demonstrated success supporting regulatory submissions (IND, CTA, BLA), with deep expertise in phase‑appropriate method development and validation, analytical control strategies, and cGMP requirements.
- Proven leader with strong communication skills, capable of managing biologics program deliverables in a fast‑paced environment; experience in mAb-mAb combination product analysis is a plus.
- Excellent communication skills and the ability to work effectively in a fast-paced environment.
- Experience in a small company or start-up environment is a plus.
Benefits
- 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
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
analytical developmentquality controlmethod developmentmethod validationanalytical assaysmass spectrometrybiophysical-structural analysisparticle characterizationsurfactant analysisregulatory submissions
Soft Skills
strategic leadershipcommunication skillsscientific rigorcontinuous improvementproject managementteam collaborationfast-paced environmentproblem-solvinginterpersonal skillsadaptability