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Life scientist - clinical supply (m/f/d)

Planegg
CatalYm GmbH
Scientist
Inserat online seit: 11 Februar
Beschreibung

Introduction CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us! (Senior) Clinical Trial Supply Manager (f/m/d) Festanstellung, Vollzeit · CatalYm GmbH Your mission As (Senior) Clinical Trial Supply Manager, you will ensure the timely and reliable supply of investigational medicinal products (IMPs) and associated materials to patients participating in our clinical trials. You will manage end-to-end clinical supply execution - from forecasting and packaging through distribution and returns - working closely with CDMOs, TechOps, Clinical Operations, QA, Regulatory, and Finance to ensure seamless study delivery. Clinical Supply Execution Translate study requirements into operational supply and distribution plans. Manage demand and supply planning to ensure continuous and compliant IMP availability. Oversee packaging, labeling, QP release, distribution, and returns/destruction activities. Act as IRT system owner for supply chain (study setup, shipments, drug assignment, etc.). Vendor & CDMO Management Lead day-to-day CDMO project coordination, including regular calls and timeline tracking. Monitor packaging/labeling progress, batch documentation, release, and distribution. Manage distribution plans, logistics schedules, and timely issue resolution. Define, implement, and maintain SOPs and compliant processes. Drive vendor performance through structured governance and proactive communication. Logistics & Distribution Coordinate IMP, QC/stability sample, and DS-DP transfers and imports worldwide. Serve as point of contact for clinical-site shipment queries and troubleshooting. Define, implement, and maintain logistics SOPs and compliant processes. Ensure adherence to GDP and import/export requirements. Governance & Cross-Functional Collaboration Represent Supply in study, program, and vendor governance meetings. Align closely with TechOps, Clinical Operations, Regulatory, QA, and Finance on study readiness and execution. Track and report key supply metrics; identify and drive process improvements. Administrative & Other Duties Manage storage and transport insurance coverage. Review, approve, and track supplier invoices; ensure budget adherence. Contribute to continuous improvement initiatives and support evolving priorities. Bachelor’s or Master’s degree in Supply Chain, Logistics, Life Sciences, or related discipline. 8 - 12 years’ experience in clinical trial supply management, ideally in oncology or biologics. Proven experience managing CDMOs and logistics vendors (packaging, labeling, distribution). Strong knowledge of GxP, GDP, IRT, QP release, import/export, and cold-chain operations. Strong project-management, problem-solving, and stakeholder-communication skills. Hands-on, execution-focused mindset; comfortable working autonomously in a fast-paced biotech environment. Fluent in English (German a plus); occasional travel to vendors or partners. Contribute directly to the success of cutting-edge oncology programs. Be part of an agile, collaborative biotech environment with visible impact. Enjoy flexibility, ownership, and professional growth within a supportive culture.

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