Associate Director – Drug Product Development

🕒 Julho 29

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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

• The Associate Director of Drug Product Development supports the planning and execution of the overall drug product (DP) development strategy from clinical development through commercialization for multi-component biologic drug products, including monoclonal antibodies (mAbs) and synthetic oligonucleotides. • This role provides technical expertise and operational oversight for formulation development, formulation and process robustness characterization, GMP manufacturing, process and product characterization, process validation, and commercial readiness while working closely with external CDMOs. • The Associate Director is responsible for planning, supervising, and supporting drug product development activities throughout the product lifecycle and overseeing outsourced development and manufacturing activities in a virtual operating environment. • This position ensures high-quality execution, adherence to project timelines, and compliance with regulatory and quality requirements across formulation development, process optimization, robustness characterization, GMP production, technology transfer, process characterization, process validation, and commercial manufacturing. • Experience with Design of Experiments (DoE), Quality by Design (QbD), and risk-based process development approaches is highly desirable. • This role requires close collaboration with Drug Substance Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Supply Chain, and other cross-functional teams to advance therapeutic candidates from development through commercialization.

🎯 Requisitos

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, Bioengineering, or a related scientific discipline with a minimum of 5 years of relevant biopharmaceutical industry experience; or M.S. in a related scientific discipline with a minimum of 10 years of relevant biopharmaceutical industry experience. • Demonstrated experience in biologic drug product development, with expertise in formulation development, formulation robustness characterization, process development, technology transfer, and GMP manufacturing. • Experience with monoclonal antibodies is strongly preferred; experience with oligonucleotide therapeutics is highly desirable. • Extensive knowledge of formulation development for liquid and lyophilized injectable products, including formulation optimization, stability assessment, manufacturability, and commercial product lifecycle management. • Strong understanding of drug product process development, scale-up, process characterization, process validation, continued process verification (CPV), aseptic fill/finish manufacturing, and commercial manufacturing readiness. • Broad knowledge of Chemistry, Manufacturing and Controls (CMC), including drug substance and drug product development, analytical development, quality systems, regulatory requirements, and manufacturing technologies. • Working knowledge of combination products, prefilled syringes, autoinjectors, and other injectable drug delivery systems is preferred. • Extensive knowledge of cGMP, GLP, ICH guidelines, FDA regulations, and other applicable global regulatory requirements. • Demonstrated experience authoring and supporting CMC documentation for regulatory submissions, including INDs, BLAs, IMPDs, and/or MAAs. • Proven experience managing external development and manufacturing partners, including CDMOs, CROs, and technical consultants, in a virtual development environment. • Demonstrated technical expertise in applying Quality by Design (QbD), risk management, and Design of Experiments (DoE) principles to drug product development. • Experience in oncology, immuno-oncology, and/or combination drug-device products is preferred. • Strong scientific and technical expertise in biologic drug product formulation development, process development, manufacturing, and CMC development. • Excellent verbal, written, presentation, technical writing, editing, and scientific communication skills. • Demonstrated ability to collaborate effectively with cross-functional teams and external partners, including Drug Substance Development, Analytical Development, Manufacturing, Quality Assurance, Regulatory Affairs, and CDMOs. • Strong analytical and problem-solving skills with the ability to independently evaluate complex technical issues and develop practical, science-based solutions. • Demonstrated ability to provide technical oversight and scientific guidance to external development and manufacturing partners in a virtual development environment. • Self-motivated, detail-oriented, and capable of working effectively in a fast-paced, collaborative, and matrixed environment. • Knowledge of Quality by Design (QbD), risk-based development, Design of Experiments (DoE), and applicable ICH, FDA, and global regulatory expectations for biologic drug products. • Knowledge of the competitive landscape, emerging technologies, and regulatory trends in biologics and immuno-oncology drug development is desirable. • Proficiency in both English and Mandarin is highly desirable. • Willingness to travel domestically and internationally as business needs require. • Willingness to work flexible hours, including early morning and late evening/night meetings, to effectively collaborate with global teams, CDMOs, and CROs.

🏖️ Benefícios

• This position generally is eligible for cash incentive compensation • equity incentive compensation • employee benefits under the Company’s benefit plans