Alnylam Pharmaceuticals, Inc.
Associate Director, Local Regulatory Lead - Switzerland and Austria(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Zug
AP
Apellis Pharmaceuticals, Inc.1 Monat
Senior Manager, Drug Substance MSAT(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Zug
Nejo KI-Zusammenfassung
In this role, you will lead the technical transfer and validation processes for drug substance manufacturing, collaborating with cross-functional teams to ensure compliance and optimize operations while addressing technical challenges directly.
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Anforderungen
- •Bachelor’s degree in life sciences or engineering
- •Extensive experience in cGMP development and manufacturing
- •Deep knowledge of pharmaceutical processes and technologies
- •Proven track record in MSAT or related fields
- •Experience in process validation and lifecycle management
- •Familiarity with CTD Module 3 authorship and regulatory standards
- •Expertise in at least two modalities (e.g., peptides, oligonucleotides, biologics)
- •Strong attention to detail and hands-on project management
- •Excellent technical, communication, problem-solving, and organizational skills
- •Effective team player with ability to build strong relationships
- •Valid passport and ability to travel
- •Eligibility to work in Switzerland
Bachelor-Abschluss
ODER
Master-Abschluss
Berufserfahrung
ca. 4 – 6 Jahre
Deine Aufgaben
- •Serve as MSAT technical expert on projects
- •Oversee product launch and tech transfer
- •Conduct process characterization and validation
- •Support risk management and troubleshooting
- •Manage development and manufacturing activities
- •Lead technical transfer and lifecycle planning
- •Proactively resolve technical challenges and deviations
- •Ensure qualification and validation of processes and equipment
- •Collaborate with cross-functional teams for tech transfer
- •Build relationships with development and manufacturing partners
- •Confirm equipment qualification during process validation
- •Identify opportunities for continuous process improvement
- •Support evaluation of major deviations and root cause analysis
- •Apply risk management tools throughout lifecycle management
- •Develop data management processes for operational analysis
- •Contribute to writing and reviewing regulatory submission sections
Sprachen
Englisch – verhandlungssicher
Deine Vorteile
Sonstige Vorteile
- •Comprehensive benefits package
Flexibles Arbeiten
- •Flexible time off
Mehr Urlaubstage
- •Summer and winter shutdowns
Großzügige Elternzeit
- •Paid family leave
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Apellis Pharmaceuticals, Inc. 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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