Associate Director, Analytical Sciences, Attribute Characterization

🕒 Maio 27

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Spyre Therapeutics

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🧬 Biotecnologia

💊 Farmacêutico

Biotechnology • Pharmaceuticals

A Spyre Therapeutics é uma empresa biofarmacêutica focada no desenvolvimento de terapias para Doenças Inflamatórias Intestinais (DII). A empresa está comprometida em criar anticorpos de melhor classe, combinações terapêuticas racionais e em empregar abordagens de imunologia de precisão para aumentar a eficácia e conveniência do tratamento para pacientes com DII. Com uma equipe experiente em desenvolver e comercializar tratamentos para várias doenças, a Spyre Therapeutics é dedicada a melhorar as opções de tratamento e os resultados para os pacientes por meio de pesquisas avançadas em imunologia. A empresa promove um ambiente colaborativo e inovador para alcançar sua missão de fornecer novas opções de tratamento promissoras para DII.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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.