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Senior Scientist, Ball...

Created 11/06/2022
Reference 135
Category Pharmaceutical
Job type Full Time
Country Denmark
City Ballerup
Zip 2750
Salary Competitive
Role Description

Senior Scientist (Denmark)

Join our Analytical CMC Support team in a cross-functional environment

LEO Pharma has embarked on a very ambitious journey to become the world's preferred dermatology care partner and that is why we need you. If you are motivated by having high level impact, visibility, and responsibility you can now take an active part in this transformation process. As a Senior Scientist in our Analytical CMC Support / Global MSAT Pharmaceutical Product Support department you will get the opportunity of making a significant difference for people with serious skin diseases all over the world.

Overall Objective

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

• Analytical support

• Method validation 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

Your Qualifications/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.

Your New Team

You will join a team of 5 scientifically skilled and experienced colleagues with an analytical chemistry background who besides have a lot of knowledge also care highly about their colleagues. Also, you will be part of cross-functional teams within LEO Pharma working with colleagues in different parts of the organisation and at different LEO Pharma sites.

Our work environment is characterised by knowledge sharing, open dialogue, and a mutually supporting atmosphere.

Join our mission to help more people achieve healthy skin

Hundreds of millions of people around the globe are suffering from an untreated skin disease. Helping these people to get a better life is what LEO Pharma is all about. By understanding their needs and wishes we will improve existing treatments and break new land to uncover the solutions of tomorrow.

By joining LEO Pharma, you will get the opportunity to create results, develop yourself among highly skilled colleagues while taking on our quest to become the preferred dermatology care partner improving people's lives around the world and at the same time create profitable growth.

Contact and application

If you have questions, please do not hesitate to contact Gitte Gotholdt Anskjær, Manager for Analytical CMC Support, at +45 53 78 26 00. Please apply via the link at our website and remember to attach application and CV. We will be evaluating candidates as we receive the applications - so please apply as soon as possible and preferably before 05.07.2022 .

About LEO Pharma

LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 5,000 people worldwide. For more information, visit www.leo-pharma.com.

Let's pioneer together
At LEO Pharma, we help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration, and curiosity, and we are at the forefront of science in developing new medicines. For us, pioneering together is about constantly improving and extending what's possible for each other, our company, and our patients.

At LEO Pharma, we welcome and consider applications from all qualified candidates because we believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions for LEO Pharma and meet the needs of the wonderfully diverse marketplace we operate in.

For certain positions, LEO Pharma might complete a background check conducted by a third party.