Senior Director of Analytical Development

🕒 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

• Provide strategic and operational leadership for all analytical development and analytical quality control activities supporting late‑phase drug substance development, drug product formulation discovery, and drug product manufacturing and formulation development within the CMC group • Oversee analytical method development, qualification, validation, transfer, and lifecycle management for single‑ and multi‑component biological products, with emphasis on antibodies and oligonucleotides • Lead and develop an internal analytical organization, directly managing a team of Managers, Associate Directors, and Director across method development and analytical QC • Provide technical and managerial oversight of external CROs, CMOs, and testing laboratories • Collaborate with formulation, manufacturing, quality, regulatory, and project teams to ensure phase‑appropriate, compliant, and efficient analytical strategies that support clinical and future commercial development.

🎯 Requisitos

• Master or PhD in Chemistry, Biochemistry, or Analytical Science • At least 15 years of experience in analytical development and validation activities for biologicals, including product development and manufacturing • Experience with liquid biological injectable dosage forms, drug formulations of individual and combination products, is highly preferred • Experience with analytical techniques applicable for characterization of proteins, antibodies and/or oligonucleotides highly preferred • Experience in complex single or tandem mass-spectrometry technologies used for characterization of proteins, oligonucleotides and their impurities is highly valued • Comprehensive understanding of the dosage form manufacturing process development, scale-up, optimization and validation processes • Strong scientific and operational background in the optimization and validation of compendial, biochemistry, HPLC, immunochemical and cell-based assays • Proven ability to provide analytical expertise on programs/project teams for pre-clinical and clinical studies with a wide variety of techniques and technologies • Experience working in a GMP/GLP regulated environment and deep understanding of phase appropriate method qualification, validation, sample analysis, GLP, GMP requirements, ICH guidelines and FDA guidance • Experience authoring and reviewing IND and/or BLA submissions • Expert knowledge of advanced principles, concepts, and theory related to product and process development. • Experience in preparing budget and managing expenses • Skilled at managing CROs and CDMOs • Strong leadership, organizational, and project management skills • Excellent written and verbal communication skills; strong technical writing and document review capabilities • Ability to operate effectively in a remote and virtual work environment • Demonstrated ability to collaborate across cross‑functional and geographically distributed teams • Detail‑oriented with exceptional documentation practices • Knowledge of U.S. and Chinese Pharmacopeia methods for biologic drugs is a plus • Proficiency in English required; Mandarin proficiency is a plus. • Flexibility to travel domestically and internationally as needed.

🏖️ Benefícios

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