Lonza
Global MSAT Lyophilization Equipment and Process Lead(m/w/x)
Vollzeitnur vor OrtSenior
Stein (AR)
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CHCH12 Lonza AG
Global MSAT Drug Product Qualification and Validation Lead(m/w/x)
Stein (AR)
VollzeitVor OrtSenior
Data Science
Nejo KI-Zusammenfassung
Defining global qualification strategies for aseptic drug product manufacturing, covering thawing, compounding, filling, and lyophilization processes. Expertise in process validation for sterile biologics, including lyophilized formats, required. Relocation assistance available.
Anforderungen
- Ph.D. in pharmaceutical sciences, engineering, biochemistry, or related field, or equivalent experience
- Expertise in equipment qualification for aseptic drug product manufacturing
- Extensive experience in process validation for sterile biologics, including lyophilized and liquid formats
- Proven experience with regulatory submissions and pre‑approval inspections
- Strong statistical skills for qualification, validation, and CPV; Data Science certification or Lean Six Sigma Black Belt preferred
- Knowledge of risk assessment, deviation management, change control, and root cause analysis
- Excellent English communication, documentation, leadership, and cross‑functional collaboration skills
Aufgaben
- Lead global process control strategy for drug product manufacturing
- Own global strategies for equipment qualification, process validation, and continued process verification
- Define and govern global SOPs, standards, templates, and tools aligned with regulations
- Own qualification strategy for thawing, compounding, filling, lyophilization, and crimping
- Guide Tech Transfer and local MSAT teams on validation strategies and sampling plans
- Review and approve validation documentation
- Analyze production data using appropriate statistical methods
- Act as subject-matter expert during health authority inspections
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – verhandlungssicher
Benefits
Boni & Prämien
- Compensation programs that recognize high performance
Mitarbeiterrabatte
- Numerous lifestyle benefits
- Leisure benefits
Familienfreundlichkeit
- Family benefits
Sonstige Vorteile
- Relocation assistance
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CH12 Lonza 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?
- CH12 Lonza AG
Head MSAT, Drug Product Stein(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR) - Lonza
Senior QA Expert - Equipment Qualification & Validation(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR) - Lonza
MSAT Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenStein (AR) - Lonza
Senior Global Technology Transfer Lead(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR)
CHCH12 Lonza AG
Global MSAT Drug Product Qualification and Validation Lead(m/w/x)
Stein (AR)
VollzeitVor OrtSenior
Data Science
Nejo KI-Zusammenfassung
Defining global qualification strategies for aseptic drug product manufacturing, covering thawing, compounding, filling, and lyophilization processes. Expertise in process validation for sterile biologics, including lyophilized formats, required. Relocation assistance available.
Anforderungen
- Ph.D. in pharmaceutical sciences, engineering, biochemistry, or related field, or equivalent experience
- Expertise in equipment qualification for aseptic drug product manufacturing
- Extensive experience in process validation for sterile biologics, including lyophilized and liquid formats
- Proven experience with regulatory submissions and pre‑approval inspections
- Strong statistical skills for qualification, validation, and CPV; Data Science certification or Lean Six Sigma Black Belt preferred
- Knowledge of risk assessment, deviation management, change control, and root cause analysis
- Excellent English communication, documentation, leadership, and cross‑functional collaboration skills
Aufgaben
- Lead global process control strategy for drug product manufacturing
- Own global strategies for equipment qualification, process validation, and continued process verification
- Define and govern global SOPs, standards, templates, and tools aligned with regulations
- Own qualification strategy for thawing, compounding, filling, lyophilization, and crimping
- Guide Tech Transfer and local MSAT teams on validation strategies and sampling plans
- Review and approve validation documentation
- Analyze production data using appropriate statistical methods
- Act as subject-matter expert during health authority inspections
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Doktor / Ph.D.
Sprachen
- Englisch – verhandlungssicher
Benefits
Boni & Prämien
- Compensation programs that recognize high performance
Mitarbeiterrabatte
- Numerous lifestyle benefits
- Leisure benefits
Familienfreundlichkeit
- Family benefits
Sonstige Vorteile
- Relocation assistance
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CH12 Lonza 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
CH12 Lonza AG
Branche
Pharmaceuticals
Beschreibung
The company is a global leader in life sciences, dedicated to improving lives through innovative solutions.
Noch nicht perfekt?
- Lonza
Global MSAT Lyophilization Equipment and Process Lead(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR) - CH12 Lonza AG
Head MSAT, Drug Product Stein(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR) - Lonza
Senior QA Expert - Equipment Qualification & Validation(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR) - Lonza
MSAT Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenStein (AR) - Lonza
Senior Global Technology Transfer Lead(m/w/x)
Vollzeitnur vor OrtSeniorStein (AR)