BioNTech SE
Director Manufacturing Sciences & Technology(m/w/x)
Vollzeitnur vor OrtSenior
Mainz
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Leading small molecule drug substance manufacturing for cancer and infectious disease therapies. GMP API manufacturing and process development expertise required. Flexible hours, vacation account, digital learning.
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Anforderungen
- Master’s or PhD in Organic Chemistry, Process Chemistry, Chemical Engineering, or Pharmaceutical Sciences
- Strong GMP manufacturing experience of APIs/small molecule drug substances or chemical process development
- Experience with linker-payloads or ADC-related materials (strong plus)
- Solid understanding of chemical manufacturing processes
- Expertise in transfer optimization, scale-up, lifecycle management & troubleshooting within GMP
- Hands-on expertise with deviations, change controls, CAPAs, investigations, risk assessments
- Hands-on expertise with qualification/validation documentation under compliance frameworks
- Familiarity with regulatory expectations for small molecule manufacturing
- Contributions towards IND/IMPD/BLA/MAA submissions or equivalent filings globally
- Excellent stakeholder communication skills
- Structured problem-solving abilities
- Adaptability amidst fast-paced operational demands
- Fluent English communication skills (written and spoken)
- Chinese language skills (plus)
Aufgaben
- Provide scientific and technical leadership for small molecule drug substance manufacturing
- Focus on manufacturing processes, process understanding, and process robustness
- Manage scale-up, troubleshooting, and lifecycle management for clinical and commercial programs
- Act as a key interface between internal technical functions and external manufacturing partners
- Ensure processes are transferred, executed, and continuously improved in a compliant manner
- Maintain technical oversight of manufacturing activities
- Support process-related investigations and changes
- Contribute to robust supply for complex pharmaceutical products
- Provide scientific and technical support for linker-payload manufacturing processes
- Act as a process-focused subject matter expert
- Maintain deep technical understanding of manufacturing processes
- Serve as a key contact for process performance, changes, and operational troubleshooting
- Support process scale-up, technology transfer, and process validation readiness
- Drive manufacturing investigations, root-cause analyses, and deviations
- Support change controls, CAPAs, risk assessments, and process improvement measures
- Review, generate, and approve technical documentation
- Create manufacturing instructions, validation/qualification documents, and investigation reports
- Prepare process transfer packages and regulatory support documentation
- Collaborate with internal stakeholders like Technical Development/CMC teams
- Work with external CDMOs/CMOs to ensure seamless communication and alignment
- Contribute to harmonization of processes across sites
- Monitor performance using KPIs and risk management tools
- Drive continuous improvement initiatives
- Provide input to regulatory submissions and health authority responses
Berufserfahrung
5 Jahre
Ausbildung
Master-Abschluss
Sprachen
Englisch – fließend
Chinesisch – Grundkenntnisse
Benefits
Flexibles Arbeiten
- Flexible hours
Mehr Urlaubstage
- Vacation account
Weiterbildungsangebote
- Digital Learning
- LinkedIn Learning
Karriere- und Weiterentwicklung
- Performance and talent development
- Leadership development
Sonstige Vorteile
- Apprenticeships
- Support for your full potential
Startup-Atmosphäre
- Voice at the table
Lockere Unternehmenskultur
- Culture on an equal footing
Sinnstiftende Arbeit
- Opportunities to shape and impact
Firmenfahrrad
- Company bike
Öffi Tickets
- Job ticket
- Deutschlandticket
Betriebliche Altersvorsorge
- Employer-funded pension
Kinderbetreuung
- Childcare
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens BioNTech SE 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.
Zur Originalanzeige bei BioNTech SEÜber das Unternehmen
BI
PharmaceuticalsMainz
Das Unternehmen entwickelt bahnbrechende Medikamente zur Verbesserung der globalen Gesundheit und zur Bekämpfung von Krankheiten.
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