(Associate) Director Protein & ADC Drug Product(m/w/x)

Beschreibung

In this role, you will drive the drug product strategy for protein-based therapeutics, bridging the gap between lab-scale processes and commercial manufacturing while managing vital CDMO partnerships.

Anforderungen

• •Master’s degree, PhD, or comparable qualification
• •Seven years of relevant professional experience
• •Experience in late-stage DP process development
• •Understanding of drug development stages
• •Experience in formulation development or lyophilization
• •Experience in clinical in-use studies
• •Sound GMP knowledge
• •Experience with regulatory filings for biologicals
• •Leadership skills and assertiveness
• •Ability to work in cross-functional teams
• •Excellent communication and negotiation skills
• •Ability to communicate complex technical matters

Aufgaben

• •Lead external development and manufacturing for protein-based therapeutics
• •Provide scientific input for drug product development programs
• •Review and approve external regulatory development documentation
• •Establish and execute drug product development strategies
• •Manage technical collaborations with internal and external partners
• •Create development reports and risk analysis documentation
• •Oversee drug product technical transfers between manufacturing sites
• •Support process scale-up to commercial GMP manufacturing
• •Coordinate clinical in-use studies and pharmacy manual reviews
• •Manage CMC timelines and implement proactive risk mitigation
• •Drive data-driven decision making for strategic CMC discussions
• •Serve as the primary contact for CDMO partners

Tools & Technologien