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APApellis Pharmaceuticals, Inc.
Senior Manager, Drug Substance MSAT(m/w/x)
Vollzeitmit HomeofficeSenior
Nejo KI-Zusammenfassung
MSAT technical expertise for drug substance therapies, overseeing product launch and tech transfer for geographic atrophy treatments. Extensive cGMP development and manufacturing experience, with proven MSAT track record, required. Summer and winter shutdowns, paid family leave.
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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
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
Berufserfahrung
ca. 4 - 6 Jahre
Ausbildung
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Benefits
Sonstige Vorteile
- Comprehensive benefits package
Flexibles Arbeiten
- Flexible time off
Mehr Urlaubstage
- Summer and winter shutdowns
Großzügige Elternzeit
- Paid family leave
Von Nejo automatisch aufbereitet
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.
Zur Originalanzeige bei Apellis Pharmaceuticals, Inc.Über das Unternehmen
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PharmaceuticalsZug
The company develops life-changing therapies for challenging diseases, including the first therapy for geographic atrophy.
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