Associate Director, CMC Analytical Development – Separation

🕒 Julho 27

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Syncromune®

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2020

🧬 Biotecnologia

💊 Farmacêutico

🏥 Saúde

💰 $111.828.793 Series A - Syncromune em 2024-12

Biotechnology • Pharmaceuticals • Healthcare

A Syncromune é uma empresa em estágio clínico desenvolvendo uma plataforma inovadora de imunoterapia contra o câncer intratumoral chamada SYNC-T. A plataforma é projetada para ser administrada diretamente nos tumores-alvo para sincronizar o sistema imunológico a fim de reconhecer e destruir o câncer por todo o corpo. Sua terapia investigacional principal, SV-102, está sendo avaliada no estudo LEGION-100 de Fase 2 para câncer de próstata resistente à castração metastático. Os materiais da empresa são direcionados a profissionais de saúde e destacam que seus compostos são investigacionais e ainda não foram aprovados pelas autoridades regulatórias.

Descrição

• Oversee the execution of the analytical strategy for drug substance and drug product development across all phases of clinical development and commercialization. • Oversee method development, validation, transfer, and lifecycle management to ensure compliance with regulatory requirements and alignment with company objectives. • Define and implement analytical development strategies to support CMC programs from early development through commercialization. • Provide technical leadership in analytical sciences, including chromatography, spectroscopy, and characterization techniques. • Guide analytical development activities at CDMO and CTL, including method development, optimization, transfer, validation, troubleshooting, and lifecycle management for GMP test methods for DS and DP. • Guide extended characterizations in support of comparability and regulatory applications. • Foster collaboration with cross-functional groups including Process Development, Quality, and Regulatory Affairs. • Author and review analytical sections of regulatory submissions (IND, IMPD, NDA, BLA). • Ensure adherence to GMP, ICH, and FDA guidelines for analytical activities. • Drive continuous improvement and innovation in analytical technologies and processes. • Supervise CDMO, CTL, and external resources (such as consultants).

🎯 Requisitos

• Ph.D. or M.S. degree in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related field. • 5+ years of pharmaceutical or biotechnology industry experience specializing in analytical development. • Working knowledge of cGMP, ICH, and regulatory guidelines. • Hands-on experience managing global CTLs and CDMOs. • Strong technical expertise in separation science, such as liquid chromatography or mass spectrometry. • Strong technical experience in at least one of the modalities: monoclonal antibody and/or oligonucleotide. • Experience in method development, validation, and lifecycle management for QC methods. • Good to have experience in complex drug products, such as co-formulation, multi-components, conjugates, etc. • Good to have experience in extended characterization & comparability studies to support BLA submission. • Good to have experience in authoring technical and scientific documents for regulatory submissions, including IND and BLA filings. • Good to have late phase experience, such as PPQ and commercialization. • Candidates proficient in both English and Mandarin are highly encouraged to apply. • Ability to work in a fast-paced virtual environment. • Flexibility to travel domestically and internationally as required.

🏖️ Benefícios

• cash incentive compensation • equity incentive compensation • employee benefits under the Company’s benefit plans