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.