Senior CMC Project Lead in Neuenburg am Rhein

Senior CMC Project Lead in Neuenburg am Rhein

Neuenburg am Rhein Vollzeit Vor Ort
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You will oversee a part of the CMC development activities and GMP manufacturing for our innovative bi-/multi-specific antibody programs, working closely with CDMOs, CROs, and cross-functional internal teams to ensure successful delivery of development milestones. Key Responsibilities Lead a part of the CMC development activities including Cell Line Development, Upstream & Downstream Processing, Formulation, and Analytical Development through external partners. Oversee a part of the GMP manufacturing of drug substance and drug product for clinical programs. Serve as the primary point of contact for CDMOs and CROs, managing outsourced activities, timelines, and deliverables. Drive technology transfer and external manufacturing activities as a key member of project teams. Partner with CMC Strategy, Regulatory Affairs, and Project Management teams to ensure robust supply planning and regulatory readiness. Present project progress, risks, and mitigation plans to senior leadership and stakeholders. Contribute to budget planning, forecasting, and critical CMC documentation. We are seeking a collaborative and results-oriented professional with: Strong experience in biologics CMC development and external manufacturing management. Proven ability to manage complex cross-functional projects and external partnerships. Excellent communication, stakeholder management, negotiation, and problem-solving skills. Experience working within a global, dynamic, and innovative environment. #J-18808-Ljbffr

Senior CMC Project Lead in Neuenburg am Rhein Arbeitgeber: IGI

IGI in Lausanne bietet eine inspirierende Arbeitsumgebung, die Innovation und Zusammenarbeit fördert. Als Arbeitgeber legen wir großen Wert auf die berufliche Weiterentwicklung unserer Mitarbeiter und bieten zahlreiche Möglichkeiten zur Weiterbildung und Karriereförderung. Unsere moderne Ausstattung und der interdisziplinäre Austausch machen uns zu einem attraktiven Arbeitsplatz für Wissenschaftler, die an der Spitze der Antikörperforschung stehen möchten.

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IGI Recruiting-Team