Beschreibung

In this role, you will be at the forefront of developing analytical data packages for drug-device combination products. Your day-to-day responsibilities will involve coordinating analytical tasks, managing resources, and collaborating with cross-functional teams to ensure compliance and successful product registrations.

Anforderungen

• •Master or PhD in engineering, chemical/bio analytics, or equivalent
• •Some working experience in pharmaceutical industry in combination product development
• •Proven knowledge in late phase parenteral analytical development
• •Leadership experience in managing development projects in a global matrix environment
• •Understanding and awareness of regulatory guidelines for combination product analytics
• •Experience with cGMP and relevant ISOs
• •Collaborative spirit
• •Self-driven attitude
• •High level of learning agility
• •Proficiency in English (written and spoken)

Aufgaben

• •Lead the creation of analytical data packages for drug-device combination products
• •Coordinate project-specific analytical tasks for functional attributes at all levels
• •Plan resources and budget for projects
• •Select testing laboratories based on resource availability and capabilities
• •Lead outsourced analytical project activities at CROs
• •Manage external partnerships effectively
• •Own and document drug-specific analytical methods and parameter sheets
• •Organize and align cross-functional inputs with Device/Pack Tech
• •Define and validate analytical methods and parameter sheets
• •Co-author cross-functional analytical CMC strategies and documents
• •Organize input for Justification of Specification from Device/Pack Tech and HFE
• •Contribute to and review regulatory documents for product registrations
• •Support product registrations and present at inspections with minimal support

Benefits