Beschreibung

You will lead a specialized team and coordinate global analytical activities to bring innovative biopharmaceuticals to market, ensuring high quality standards and GxP compliance throughout the development lifecycle.

Anforderungen

• •PhD in Analytics, Biochemistry, Pharmacy, or similar
• •3-5 years biopharmaceutical industry experience
• •Focus on protein analytics and characterization
• •Experience in a GMP environment preferred
• •Experience with combination products is advantageous
• •Experience developing biophysical/biochemical protein analysis methods
• •Excellent leadership skills
• •Track record in cross functional collaboration
• •Ability to influence stakeholders at all levels
• •Self-motivation and pro-active work style
• •Responsibility and result-orientation
• •Excellent teamwork and relationship building skills
• •Statistics expertise and statistical model application
• •High affinity to digitalization preferred
• •Experienced scientist status

Aufgaben

• •Lead analytical projects within global technical development teams
• •Coordinate all analytical activities for biotechnological development products
• •Manage and prioritize workload for a team of six associates
• •Set specifications and shelf life for investigational medicinal products
• •Support IND and BLA regulatory filings
• •Evaluate and implement new analytical technologies and test methods
• •Manage analytical method validation and transfer processes
• •Oversee quality control for preclinical and clinical study batches
• •Ensure GxP-compliant analytics according to current guidelines and SOPs

Tools & Technologien