Principal Scientist, Drug Product Analytical Development Principal Scientist, Drug Product Anal[...]

Principal Scientist, Drug Product Analytical Development

Eurofins

Job Description

• Work in a GLP or GMP environment with appropriate documentation and safety practices
• Lead the development and execution of analytical strategies for new drug product candidates
• Plan, direct, and review laboratory work, including method development, validation, and transfer
• Design and interpret stability studies to understand degradation mechanisms and support shelf-life assignments.
• Develop impurity control strategies aligned with regulatory expectations.
• Collaborate with formulations, process and regulatory teams to ensure seamless pharmaceutical drug development
• Collaborate with colleagues to identify appropriate analytical approaches, including use of computational predictive tools, modeling software and data visualization tools where appropriate
• Critically review and interpret scientific data to derive clear conclusions and provide direction for future work
• Mentor and guide junior scientists in analytical techniques and data interpretation.
• Evaluate and implement new strategies as needed, e.g. working with external partners
• Communicate results and conclusions through various media including presentations and technical reports
• Author relevant sections of the quality modules of regulatory submissions