Associate Director, Analytical Sciences and Attribute Characterization

Responsibilities

• Provide strategic and technical leadership for multidimensional biologics characterization to support product understanding and comparability in a phase-appropriate manner, enabling regulatory submissions for clinical development through BLA & MAA, primarily executed through global CDMO partners.
• Contribute to analytical control strategies and regulatory content development, ensuring scientific rigor, comprehensive product understanding, and assessment of process impacts on product quality attributes across DS, DP, placebo, and device manufacturing.
• Lead comparability and characterization activities at CDMOs, including review and approval of protocols, reports, and data packages, and verification of analytical results to support regulatory submissions.
• Ensure analytical activities, both internal and external, meet scientific, regulatory (FDA, EMA, ICH), and industry standards.
• Develop characterization strategies in collaboration with analytical SMEs, ensuring alignment and complementarity with QC methods for release, stability, and in-process controls.
• Partner with process (DS, DP, device) and regulatory teams to establish product-appropriate characterization and comparability plans.
• Support ADQC activities, including method development, investigations, and review of QC release and stability data, as needed.
• Establish best practices and protocols for structure-function relationships, post-translational modification (PTM) analysis, biophysical characterization, and critical quality attribute (CQA) assessment.
• Other duties as assigned.
• Ideal Candidate:
• 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

Additional Information

Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: The Associate Director, Analytical Sciences and Attribute Characterization, oversees structural and functional characterization and comparability studies across Spyre's clinical and late-stage mAb and mAb-mAb combination programs. This role is a key leader within the Analytical Development and Quality Control (ADQC) organization and reports directly to the Vice President. The position provides both strategic and operational leadership for analytical characterization and comparability, in close collaboration with internal process, analytical, and regulatory teams, as well as global CDMO partners. The Associate Director defines phase-appropriate characterization and comparability strategies that support formulation, process, and analytical development, quality control, and regulatory submissions, aligned with regulatory expectations and industry best practices. This role drives proactive planning to ensure efficient advancement of drug candidates through clinical development stages.

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