Senior Analytical Scientist (Pharmaceutical, Kastrup)

Job summary

This position involves leading analytical development for late-stage drug product projects within a collaborative environment. The role focuses on developing robust analytical methods that comply with regulatory standards and support commercial manufacturing quality control.

Qualifications

• Over 10 years of experience as a subject matter expert in analytical method development, including techniques such as liquid chromatography, CE, and SDS PAGE.
• Strong background in analytical development for drug products, including impurities and excipients.
• Proven experience in late-stage analytical method development through to submission activities and approval.
• Solid track record in authoring CTD documents and responding to regulatory inquiries.
• Demonstrated project management skills and ability to facilitate cross-functional collaboration.
• M.Sc. or Ph.D. in analytical chemistry or a related field.

Responsibilities

• Represent Analytical Development in project teams and drive strategies focused on protein modalities.
• Conduct investigations to support commercial operations and manage method life cycles.
• Oversee analytical development at CDMO/CMOs, ensuring adherence to timelines and quality standards.
• Perform analytical development tasks in a state-of-the-art laboratory setting.
• Author and review technical reports and regulatory documentation, addressing authority questions as needed.
• Coordinate analytical method transfers to internal and external partners.

Skills

• Strong analytical development and method validation expertise.
• Interest in stakeholder management and coordination with partners.
• Proficient in structured problem-solving techniques for troubleshooting.

Education

• M.Sc. or Ph.D. in analytical chemistry or a related scientific discipline.

Tools

• Experience with analytical techniques such as H/UPLC, CE, and SDS PAGE.