Associate Director, Analytical Sciences, Attribute Characterization

Spyre Therapeutics

Associate Director overseeing structural and functional characterization in biotechnology for inflammatory bowel disease and rheumatic diseases. Leading teams in analytical development and regulatory submissions.

Posted 5/27/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $175,000 - $190,000 per yearWebsite

About the role

Key responsibilities & impact

Oversee structural and functional characterization and comparability studies across Spyre’s clinical and late-stage mAb and mAb-mAb combination programs.
Provide strategic and technical leadership for multidimensional biologics characterization to support product understanding and comparability in a phase-appropriate manner.
Serve as subject matter expert (SME) in mAb and mAb-mAb combination product molecular characterization and comparability.
Contribute to analytical control strategies and regulatory content development.
Lead comparability and characterization activities at CDMOs.
Ensure analytical activities meet scientific, regulatory and industry standards.
Develop characterization strategies in collaboration with analytical SMEs.
Support ADQC activities, including method development, investigations, and review of QC release and stability data.
Establish best practices and protocols for structure–function relationships and critical quality attribute (CQA) assessment.

Requirements

What you’ll need

Advanced degree in Mass spectrometry, Biophysical chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or a related discipline, with 8+ years of biopharma industry experience in biologics analytical, formulation or process development.
Demonstrated experience and success supporting regulatory submissions (IND, CTA, BLA), with strong expertise in phase-appropriate characterization and comparability studies and associated analytical methods.
Proven leadership and effective communication skills, with the ability to manage biologics program deliverables in a fast-paced environment; experience with mAb combination products is preferred, and device testing is an advantage.
Experience leveraging artificial intelligence (AI) and machine learning (ML) to enhance analytical efficiency, automate attribute trending, and support knowledge generation and decision-making.

Benefits

Comp & perks

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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

mass spectrometrybiophysical chemistryanalytical chemistrypharmaceutical sciencesbiochemistryregulatory submissionscomparability studiesanalytical methodsmethod developmentcritical quality attribute assessment

Soft Skills

leadershipeffective communicationproject managementstrategic thinkingcollaborationproblem-solvingadaptabilityattention to detailtime managementinterpersonal skills