Detail

Salary
negotiable
Location
Ballerup, Denmark
Posted by: Leo Pharma
20 Jun
25 Views
19 Aug expires

Senior Scientist

Ballerup, Denmark
Job Description

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 

Job ID Reference
1600
Desired Skills & Experience

• 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. 

Company
  New York
LEO Pharma has embarked on a growth journey to become the preferred dermatology care partner in the world, dedicated to help people achieve healthy skin. We have an ambitious 2025 strategy, which aims to accelerate our impact in innovative therapeutics while strengthening our established portfolio and our global footprint in medical dermatology. Dermatology is an area of rapid growth and LEO Pharma´s vision is to reach 125 mill. patients worldwide by 2025. Our nimble and entrepreneurial environment allows passionate people to innovate and make a visible impact.
  Workplace
 Ballerup, Denmark