Permanent employee,Full-time· Planegg-Martinsried
Your mission
* Design and execute the global supply chain strategy across multiple studies and phases to enable drug development balancing agility, cost-efficiency, and regulatory compliance.
* Develop and scale supply chain infrastructure and operations to support early-stage clinical development through to late-stage and commercial readiness.
* Establish best practices and systems for procurement, planning, logistics, and CMO/CRO management, ensuring alignment with Quality, Regulatory, Clinical, and Finance teams.
* Drive operational excellence through KPI tracking, scenario planning, and process improvement.
Strategy
* Design and execute the global supply chain strategy across multiple studies and phases to enable drug development balancing agility, cost-efficiency, and regulatory compliance.
* Develop and scale supply chain infrastructure and operations to support early-stage clinical development through to late-stage and commercial readiness.
* Establish best practices and systems for procurement, planning, logistics, and CMO/CRO management, ensuring alignment with Quality, Regulatory, Clinical, and Finance teams.
* Drive operational excellence through KPI tracking, scenario planning, and process improvement.
Planning
* Lead collaborative demand planning process to ensure uninterrupted clinical supplies: trial forecasting, procurement, and logistics.
* Oversee end-to-end clinical supply planning: protocol design through manufacturing, packaging, labeling, distribution, and inventory management.
Sourcing
* Negotiate and manage global vendor relationships (CMOs, CDMOs, 3PLs) and ensure continuity of supply.
* Execute comparator and combination drug sourcing strategies
Compliance and Risk Mitigation
* Support global regulatory submissions and inspections; ensure all activities meet FDA, EMA, and other international requirements.
* Ensure all suppliers comply with import/export and regulatory standards.
* Oversee quality documentation (Deviations, CAPAs, Change Controls, etc.) and support SOP development and continuous improvement for cGxP compliance.
Leadership and Management
* Collaborate cross-functionally with Clinical Ops, Technical Ops, QA, Regulatory, Finance, and Program Teams.
* Build and scale a high-performing supply chain team as the company matures
* Manage budgets and contracts
Your profile
* Bachelor’s degree in Supply Chain, Life Sciences, Engineering, or related field; MBA or advanced degree preferred. APICS certification or coursework is desired.
* 10+ years of progressive supply chain experience in biotech/pharma, including clinical and commercial-stage leadership.
* Proven expertise in clinical supply operations (IRT systems, labeling, cold chain, reverse logistics, etc.).
* Strong knowledge of GxP, GMP, global regulatory standards (CFR, Annex 13, EU CTR), USP/EP.
* Experience with comparator sourcing and global study blinding practices.
* Must be knowledgeable in US, EU, and ROW clinical supply labeling requirements and the QP review/release/certification process for European clinical supplies.
* Experience with both ambient and cold chain products.
* Skilled in strategic planning, project management, contract negotiation, and vendor management.
* Excellent communication, leadership, and cross-functional collaboration skills.
* Dynamic and energetic, hands-on approach to challenges.
* Willingness to engage in business travel to various company offices, suppliers, and partners as required.
Why us?
* Impact & Growth– Be part of a dynamic, goal-oriented company where your contributionstruly make a difference.
* Innovation– Work on groundbreaking immuno-oncology therapies with amission-driven team.
* Collaboration & Culture– Enjoy amulticultural, open, and appreciativework environment anddirect communication channels.
* Additional Benefits– Competitive compensation, professional development opportunities, and more!
* Impact & Growth– Be part of a dynamic, goal-oriented company where your contributionstruly make a difference.
* Innovation– Work on groundbreaking immuno-oncology therapies with amission-driven team.
* Collaboration & Culture– Enjoy amulticultural, open, and appreciativework environment anddirect communication channels.
* Additional Benefits– Competitive compensation, professional development opportunities, and more!
Join us in shaping the future of cancer therapy!
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!
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