Thermo Fisher Scientific
.USP Manufacturing Specialist(m/w/x)
Vollzeitnur vor OrtJunior
Lengnau
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
SISIEGFRIED DiNAMIQS AG
Manufacturing Specialist / Sr. Manufacturing Specialist – Downstream Processing (DSP)/ Drug Product(m/w/x)
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VollzeitVor OrtJunior
Nejo KI-Zusammenfassung
Executing downstream processing for viral vector gene therapies, including chromatography and filtration. Hands-on experience with DSP operations and cGMP regulations required. 5 weeks holidays, flexible working hours.
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Anforderungen
- Bachelor's degree in Biology, Biotechnology, Biochemistry, Chemical Engineering, or related scientific field with 3–6 years of relevant experience, or Master's degree with 1–3 years of relevant experience. Equivalent combinations of education and experience may be considered.
- Experience in biopharmaceutical, gene therapy, cell therapy, or viral vector manufacturing with DSP focus
- Hands-on experience with chromatography, filtration, and TFF/UF-DF operations
- Working knowledge of cGMP regulations, cleanroom operations, aseptic processing, and GMP documentation
- Experience with manufacturing systems like MES, LIMS, or SAP is preferred
- Experience in Drug Product manufacturing (formulation, sterile filtration, aseptic fill-finish) is a plus
- Experience writing and maintaining SOPs and work instructions
- Strong troubleshooting, communication, and documentation skills
- Willingness to support flexible working hours, including weekends
- English speaking and writing, German is a plus
- Viral vector purification processes (e.g., AAV, lentivirus, adenovirus)
- DSP operations including chromatography, TFF, UF/DF, and filtration
- GMP batch execution, documentation, and electronic manufacturing systems
- Manufacturing process and equipment troubleshooting
- Knowledge of contamination control and aseptic manufacturing practices
- Team-oriented with strong communication and collaboration skills
- Hands-on, proactive problem solver
- Able to perform effectively in a fast-paced GMP manufacturing environment
- High level of accountability, quality mindset, and attention to detail
Aufgaben
- Execute DSP operations including chromatography, filtration, TFF, and UF/DF
- Perform manufacturing activities according to batch records, SOPs, and GMP requirements
- Prepare, operate, and maintain manufacturing equipment
- Clean and monitor manufacturing equipment
- Prepare buffers and handle materials
- Manage inventory
- Support technology transfer and process implementation
- Troubleshoot process and equipment issues
- Conduct deviation investigations and root cause analyses
- Implement CAPA measures
- Complete GMP documentation and electronic systems (MES, LIMS, SAP) accurately and timely
- Contribute to continuous improvement and operational excellence
- Collaborate with Quality, Engineering, Process Development, and Analytical teams
Berufserfahrung
- 1 - 6 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
Tools & Technologien
- MES
- LIMS
- SAP
- AAV
- lentivirus
- adenovirus
- chromatography
- TFF
- UF/DF
- filtration
Benefits
Flexibles Arbeiten
- Flexible working hours
- Combine family, leisure time and career
Sonstige Vorteile
- Weekend support
Sinnstiftende Arbeit
- Impactful work
- Innovative gene therapy projects
Weiterbildungsangebote
- Learning opportunities
- Diverse skill development
Startup-Atmosphäre
- Dynamic environment
- Fast-paced environment
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.
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