Associate Director, Biologics Formulation Development

🕒 Maio 26

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Dianthus Therapeutics, Inc.

SiteLinkedInTodas as Vagas

1 - 10 funcionários

Fundada em 2017

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $100.000.000 Private Equity Round em 2022-04

Healthcare • Biotechnology • Pharmaceuticals

Dianthus Therapeutics, Inc. é uma empresa de biotecnologia em estágio clínico focada no desenvolvimento de novos anticorpos monoclonais para tratar doenças autoimunes e inflamatórias graves. A companhia utiliza tecnologias avançadas de engenharia de anticorpos para criar terapias de próxima geração direcionadas ao sistema complemento, com seletividade e potência aprimoradas. Seu programa líder, o DNTH103, é um anticorpo monoclonal que tem como alvo a via clássica do sistema complemento para condições como miastenia gravis generalizada, neuropatia motora multifocal e polirradiculoneuropatia desmielinizante inflamatória crônica. Com sedes em Nova York e Waltham, Massachusetts, a Dianthus busca oferecer terapias transformadoras, atendendo necessidades médicas não atendidas no tratamento de doenças autoimunes.

Descrição

• Lead formulation development strategy for a new bispecific fusion protein from preclinical stage through clinical development. • Design and execute studies to assess protein stability, aggregation, degradation pathways, viscosity, and developability under relevant formulation conditions. • Develop liquid and, where appropriate, lyophilized formulations to support both IV and SC presentations. • Lead excipient screening, buffer optimization, pH optimization, surfactant selection, and stress stability studies to identify robust drug product formulations. • Drive high-concentration formulation development for subcutaneous delivery, including syringeability, injectability, and device compatibility assessments. • Partner closely with Analytical Development to establish appropriate characterization methods for formulation screening, stability assessment, and comparability studies. • Collaborate with Drug Substance, Process Development, Quality, Regulatory, Clinical Supply, and external CDMOs to ensure alignment between formulation strategy, manufacturability, and clinical needs. • Provide technical leadership for drug product process development, fill-finish considerations, container closure selection, and tech transfer activities. • Serve as the formulation subject matter expert during regulatory interactions and contribute to CMC sections of regulatory filings, including IND, IMPD, and BLA submissions. • Identify formulation-related risks early and develop mitigation strategies to support program timelines and long-term product quality. • Evaluate and implement new technologies and platform approaches to improve formulation development capabilities for complex biologics.

🎯 Requisitos

• Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or a related field with 8+ years of relevant industry experience; or M.S. with 10+ years of relevant experience. • Deep expertise in formulation development for biologics, including monoclonal antibodies, bispecific antibodies, fusion proteins, or other large-molecule therapeutics. • Strong hands-on experience with protein stability assessment, excipient selection, buffer optimization, and formulation screening for early- and late-stage development. • Demonstrated experience developing formulations for high-concentration biologics and supporting subcutaneous and intravenous presentations. • Familiarity with key challenges associated with complex protein therapeutics, including aggregation, fragmentation, oxidation, deamidation, viscosity, and interfacial instability. • Experience working with external CDMOs and managing outsourced formulation and drug product development activities. • Strong understanding of drug product manufacturing, fill-finish operations, container closure systems, and clinical supply requirements. • Familiarity with regulatory expectations for formulation and drug product development in biologics programs. • Excellent leadership, communication, and project management skills, with the ability to work effectively across multidisciplinary teams. • Prior experience supporting regulatory submissions and health authority interactions is preferred.

🏖️ Benefícios

• Flexible working arrangements • Professional development opportunities