Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)

Beschreibung

You will drive the pharmaceutical development of biological drug products by leading global strategy teams and coordinating cross-functional experts to deliver innovative, patient-centric solutions.

Anforderungen

• •BS, Master's, PhD, or equivalent qualification
• •Experience in formulation, manufacturing, or analytical development
• •Bachelor's, Master's, or PhD in science
• •Knowledge in Biologics drug product development
• •Established expert in specific technical area
• •Understanding of ICH, EMA, FDA regulations
• •Experience with novel modality projects
• •Excellent communication and stakeholder management skills
• •Interpersonal skills and matrix environment leadership
• •Structured, proactive, and reliable working style
• •Comfort with ambiguity and risk-based decision-making

Aufgaben

• •Lead biologics drug product development on global strategy teams
• •Act as the primary contact for drug product topics
• •Develop formulations, manufacturing processes, and container closure systems
• •Collaborate with cross-functional experts from discovery to operations
• •Translate expert knowledge into patient-centric development strategies
• •Execute and communicate strategies to achieve CMC project goals
• •Deliver drug product work packages for early-stage assets
• •Create regulatory documents including QTPP and CMC sections
• •Consolidate project results into high-level summary reports
• •Participate in regulatory agency interactions and scientific advice
• •Manage technical issues with local and global experts
• •Oversee drug product projects outsourced to external partners
• •Communicate project risks and strategies to management
• •Plan personnel and budgetary resource requirements
• •Distribute work packages within functional groups
• •Contribute to global drug product development initiatives

Tools & Technologien

Benefits