SIEGFRIED DiNAMIQS AG
QA Specialist(m/w/x)
Vollzeitnur vor OrtSenior
Schlieren
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SISIEGFRIED DiNAMIQS AG
Head of Manufacturing and MSAT(m/w/x)
Schlieren
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Directing viral vector gene therapy manufacturing and MSAT operations at a specialized biopharma company, including upstream, downstream, and fill-finish. Proven leadership in GMP biopharma manufacturing and MSAT, ideally biologics or ATMPs, required. 5 weeks holidays, flexible working hours.
Anforderungen
- Advanced degree in Biotechnology, Bioprocess Engineering, Chemical Engineering, or related life sciences field
- Proven leadership experience in MSAT and manufacturing within a GMP-regulated biopharmaceutical environment, ideally in biologics or ATMPs space
- Strong expertise in upstream and downstream bioprocessing and related analytical methods, ideally using viral vectors
- Experience in sterile drug product manufacturing, including F&F operations
- Solid understanding of regulatory guidelines and experience supporting audits and inspections
- Experience with digital manufacturing systems (LIMS, eBR, SAP, automation platforms) would be desired
- Strong communication, problem-solving, and organizational skills with a hands-on, solution-oriented mindset
- High skills in written and spoken English; German would be a plus
Aufgaben
- Organize manufacturing and MSAT operations for timely and budget-friendly production
- Lead upstream, downstream, fill-finish, and support manufacturing to ensure safe and compliant delivery of products
- Develop the MSAT function, focusing on technology transfer, process validation, lifecycle management, and troubleshooting
- Drive process optimization and scale-up/scale-down activities
- Conduct process characterization and continued process verification
- Ensure compliance with GMP regulations and global regulatory requirements
- Support investigations, deviations, CAPAs, risk assessments, and root cause analyses in collaboration with QA, QC, and Regulatory Affairs
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- LIMS
- eBR
- SAP
- automation platforms
Benefits
Flexibles Arbeiten
- Flexible working hours
Weiterbildungsangebote
- Learning opportunities
Sinnstiftende Arbeit
- Impactful work
Lockere Unternehmenskultur
- Creative freedom
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens SIEGFRIED DiNAMIQS AG 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.
Noch nicht perfekt?
- KLK Kolb
Production Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenHedingen - Takeda
Global Manufacturing Sciences BioProcess Lead (Sr. Manager)(m/w/x)
Vollzeitnur vor OrtSeniorZürich - Tecan
Site Manager & Head Operations(m/w/x)
Vollzeitnur vor OrtManagementMännedorf, Nänikon - CHE-106.649.671 Fisher Clinical Services GmbH
Manufacturing Professional (USP or DSP)(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLengnau
SISIEGFRIED DiNAMIQS AG
Head of Manufacturing and MSAT(m/w/x)
Schlieren
VollzeitVor OrtManagement
Nejo KI-Zusammenfassung
Directing viral vector gene therapy manufacturing and MSAT operations at a specialized biopharma company, including upstream, downstream, and fill-finish. Proven leadership in GMP biopharma manufacturing and MSAT, ideally biologics or ATMPs, required. 5 weeks holidays, flexible working hours.
Anforderungen
- Advanced degree in Biotechnology, Bioprocess Engineering, Chemical Engineering, or related life sciences field
- Proven leadership experience in MSAT and manufacturing within a GMP-regulated biopharmaceutical environment, ideally in biologics or ATMPs space
- Strong expertise in upstream and downstream bioprocessing and related analytical methods, ideally using viral vectors
- Experience in sterile drug product manufacturing, including F&F operations
- Solid understanding of regulatory guidelines and experience supporting audits and inspections
- Experience with digital manufacturing systems (LIMS, eBR, SAP, automation platforms) would be desired
- Strong communication, problem-solving, and organizational skills with a hands-on, solution-oriented mindset
- High skills in written and spoken English; German would be a plus
Aufgaben
- Organize manufacturing and MSAT operations for timely and budget-friendly production
- Lead upstream, downstream, fill-finish, and support manufacturing to ensure safe and compliant delivery of products
- Develop the MSAT function, focusing on technology transfer, process validation, lifecycle management, and troubleshooting
- Drive process optimization and scale-up/scale-down activities
- Conduct process characterization and continued process verification
- Ensure compliance with GMP regulations and global regulatory requirements
- Support investigations, deviations, CAPAs, risk assessments, and root cause analyses in collaboration with QA, QC, and Regulatory Affairs
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Tools & Technologien
- LIMS
- eBR
- SAP
- automation platforms
Benefits
Flexibles Arbeiten
- Flexible working hours
Weiterbildungsangebote
- Learning opportunities
Sinnstiftende Arbeit
- Impactful work
Lockere Unternehmenskultur
- Creative freedom
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens SIEGFRIED DiNAMIQS AG 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
SIEGFRIED DiNAMIQS AG
Branche
Pharmaceuticals
Beschreibung
The company specializes in the manufacturing of viral vector gene therapies and offers a range of services including process development and analytics.
Noch nicht perfekt?
- SIEGFRIED DiNAMIQS AG
QA Specialist(m/w/x)
Vollzeitnur vor OrtSeniorSchlieren - KLK Kolb
Production Manager(m/w/x)
Vollzeitnur vor OrtBerufserfahrenHedingen - Takeda
Global Manufacturing Sciences BioProcess Lead (Sr. Manager)(m/w/x)
Vollzeitnur vor OrtSeniorZürich - Tecan
Site Manager & Head Operations(m/w/x)
Vollzeitnur vor OrtManagementMännedorf, Nänikon - CHE-106.649.671 Fisher Clinical Services GmbH
Manufacturing Professional (USP or DSP)(m/w/x)
Vollzeitnur vor OrtBerufserfahrenLengnau