BioNTech SE
(Senior-) Director Clinical Development(m/w/x)
Vollzeitnur vor OrtSenior
Mainz, München
Neuer Job?Nejo!
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CACatalYm
(Senior) Clinical Trial Supply Manager(m/w/x)
München
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Managing IMP supply and distribution for oncology/biologics at an immunotherapy biotech, overseeing packaging, QP release, and IRT system ownership. 8-12 years clinical trial supply experience, with CDMO management, required. Flexible work options.
Anforderungen
- 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
- 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
- Fluency in English; German a plus
Aufgaben
- Translate study requirements into operational supply and distribution plans
- Manage demand and supply planning for continuous and compliant IMP availability
- Oversee packaging, labeling, QP release, distribution, and returns/destruction activities
- Act as IRT system owner for supply chain activities
- Lead day-to-day CDMO project coordination and timeline tracking
- Monitor packaging and labeling progress, batch documentation, and distribution
- Manage distribution plans and logistics schedules, resolving issues promptly
- Define, implement, and maintain SOPs and compliant processes
- Drive vendor performance through structured governance and proactive communication
- Coordinate IMP, QC/stability sample, and DS-DP transfers and imports worldwide
- Serve as the point of contact for clinical-site shipment queries and troubleshooting
- Ensure adherence to GDP and import/export requirements
- Represent Supply in study, program, and vendor governance meetings
- Align with TechOps, Clinical Operations, Regulatory, QA, and Finance on study execution
- Track and report key supply metrics and identify process improvements
- Manage storage and transport insurance coverage
- Review, approve, and track supplier invoices to ensure budget adherence
- Contribute to continuous improvement initiatives and support evolving priorities
Berufserfahrung
- 8 - 12 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Benefits
Flexibles Arbeiten
- Flexibility
Attraktive Vergütung
- Ownership
Karriere- und Weiterentwicklung
- Professional growth
Lockere Unternehmenskultur
- Supportive culture
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CatalYm erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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CACatalYm
(Senior) Clinical Trial Supply Manager(m/w/x)
München
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Managing IMP supply and distribution for oncology/biologics at an immunotherapy biotech, overseeing packaging, QP release, and IRT system ownership. 8-12 years clinical trial supply experience, with CDMO management, required. Flexible work options.
Anforderungen
- 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
- 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
- Fluency in English; German a plus
Aufgaben
- Translate study requirements into operational supply and distribution plans
- Manage demand and supply planning for continuous and compliant IMP availability
- Oversee packaging, labeling, QP release, distribution, and returns/destruction activities
- Act as IRT system owner for supply chain activities
- Lead day-to-day CDMO project coordination and timeline tracking
- Monitor packaging and labeling progress, batch documentation, and distribution
- Manage distribution plans and logistics schedules, resolving issues promptly
- Define, implement, and maintain SOPs and compliant processes
- Drive vendor performance through structured governance and proactive communication
- Coordinate IMP, QC/stability sample, and DS-DP transfers and imports worldwide
- Serve as the point of contact for clinical-site shipment queries and troubleshooting
- Ensure adherence to GDP and import/export requirements
- Represent Supply in study, program, and vendor governance meetings
- Align with TechOps, Clinical Operations, Regulatory, QA, and Finance on study execution
- Track and report key supply metrics and identify process improvements
- Manage storage and transport insurance coverage
- Review, approve, and track supplier invoices to ensure budget adherence
- Contribute to continuous improvement initiatives and support evolving priorities
Berufserfahrung
- 8 - 12 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Benefits
Flexibles Arbeiten
- Flexibility
Attraktive Vergütung
- Ownership
Karriere- und Weiterentwicklung
- Professional growth
Lockere Unternehmenskultur
- Supportive culture
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CatalYm erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
CatalYm
Branche
Healthcare
Beschreibung
CatalYm is a biotech company developing innovative immunotherapies to transform cancer patients’ lives.
Noch nicht perfekt?
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