Assoc. Dir., Engineering(m/w/x)

Anforderungen

• Understanding of regulatory requirements and partnerships
• 10 years manufacturing experience
• 5 years Bioconjugation/ADC DS manufacturing experience
• Experience leading technical transfers and manufacturing
• Proven people management and coaching experience
• Authentic and inclusive people leadership
• Ability to build collaborative internal relations
• Strong professional and interpersonal communication skills
• Ability to multi-task under deadlines
• Flexibility, independence, and organizational skills
• Knowledge of Bioconjugation Chemistry and Validation
• Analytical problem-solving and risk assessment skills
• Excellent command of English
• Lean Manufacturing or Six Sigma experience
• Project management experience
• Knowledge of worldwide regulatory requirements
• Italian and/or German language skills
• Expertise in Automation Systems and Scale-Up

Aufgaben

• Act as the primary technical interface with external partners
• Lead tech transfers and commercial manufacturing for ADC drug substance
• Manage a high-performing team of technical operations engineers
• Provide technical guidance and verify standards for external partners
• Assess technology viability in proposed process configurations
• Identify partner risks and develop mitigation plans
• Evaluate external partners for network inclusion with cross-functional teams
• Execute technical due diligence assessments at partner sites
• Execute validation strategies for new and existing products
• Resolve production issues and optimize process capacity
• Manage complex investigations across impacted manufacturing sites
• Review partner process changes, deviations, and master batch records
• Minimize effort duplication between partner and internal systems
• Drive continuous process verification and performance monitoring
• Develop efficient ways to meet regulatory requirements with partners

Berufserfahrung

AusbildungWeitere Informationen zur Ausbildungsanforderung

Sprachen

Tools & Technologien