As a Senior Scientist you will be involved in License-to-Operate and Life-Cycle-Management activities related to stability and analytical procedures for a specific established biologic portfolio within LEO Pharma. You will have responsibility within stability and analytical procedures with a focus on regulatory matters.
The key objectives include the following:
• Subject matter expert (SME) and project participation
• Be part of setting the CMC strategy for authority questions and Module 3 documents
• Respond to authority questions
• Writing/updating Module 3 documents
• Stability support
Responsibilities
• Owner and author of regulatory documentation mainly regarding stability and analytical procedures (including e.g. Characterisation of Impurities/Justification of Specification)
• Write (and coordinate) replies to authority questions related to stability and analytical procedures
• CMO support related to areas of responsibility as SME
• Deliver documentation and SME input to projects e.g. new manufacturers, technical transfers, market expansion
• Contact / link between Regulatory Affairs and Global Product Support and QC laboratories within areas of responsibility There will be cross-functional teams working with stakeholders in different parts of the organisation and in different LEO sites
• Analytical support
• Method validation support
• 10 years of experience within the pharma industry, regulatory documentation and GMP
• 5 years of experience in either stability department and/or analytical chemistry department in pharma industry
• Experience with writing Module 3 documents and answering authority questions
• Experience with an established portfolio within biologics
As a person you are thorough with a strong solution-oriented approach and customer-focused. You have a quality and operational mind-set . Your competences are enterprise thinking, ability to "connect the dots", decision quality.
Furthermore, you thrive with having a cooperation and communication with several stakeholders both internally and with external partners.