Senior Manager, Drug Substance MSAT(m/w/x)

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

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