Beschreibung

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.

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

Benefits