Principal Bioanalytical Scientist

Application deadline: 30-April- 2025 
Location: Ballerup , , Denmark 
Contract type: Permanent 
Job ID: 3109 

Are you passionate about leveraging your expertise in bioanalytical assays? Are you thrilled about joining LEO Pharma as we embark on a new chapter in our innovation strategy? Are you ready to join a dynamic team where your expertise will truly make a difference? Looking for a job with major freedom and significant impact in a cross-functional, project-driven environment?

Shape the LEO Pharma of tomorrow  
At LEO Pharma, our mission transcends the conventional. We are on an ambitious path to become the leaders in medical dermatology worldwide. If you are ready to make a difference, this role is your gateway to a world of opportunities!

In our department Translational Sciences, we share a “challenge accepted” mindset and are guided by our winning behaviors of simplification, collaboration, and accountability to achieve our goals.
LEO Pharma has set the very ambitious goal to become the world's preferred dermatology care partner. To make this come true we are expanding our pipeline within small molecules as well as biologics, and that is why we need you to unfold all of your knowledge and ideas.

Your new role
As a Principal Bioanalytical Scientist, you will be a key member of a multidisciplinary team, advancing drug development and bioanalysis. At LEO Pharma we operate according to a fully outsourced model with bioanalysis and collaborate with CROs across the globe. Your responsibilities will include method development and validation conducting sample analysis in non-clinical studies, measuring blood sample concentrations, and developing and validating analytical methods for accuracy and reliability. You will manage outsourced processes and maintain effective communication with CROs to ensure seamless collaboration. In the Translational Science team, your focus will be on bioanalytical assays, setting up, leading, and monitoring studies at CROs. 

Your key responsibilities:
•    Planning, setting up, coordinating and monitoring method development and validation of bioanalytical methods for small molecules (LC/MS assays) at CROs for TK/PK in non-clinical and clinical studies
•    Initiating and monitoring bioanalysis in non-clinical studies and clinical trials in close collaboration with CROs
•    Reviewing bioanalytical protocols and reports to ensure studies are conducted in conformity with the regulatory guidelines and according to GLP/GCP when necessary
•    Providing input non-clinical and clinical bioanalytical sections of regulatory submission documents
•    Being the point of contact for bioanalysis in project teams and trial teams
 

Your qualifcations
To succeed in this role, we imagine that you have the following qualifications:

•    A master’s degree or Ph.D. within biological sciences e.g. biology, biochemistry
•    At least 5 years of industry experience within bioanalysis of small molecules using LC/MS assays, preferably from the pharmaceutical industry or CROs where you have worked in cross-functional and cross-organizational projects
•    Solid expertise from working with outsourcing of regulated bioanalysis  
•    Experience with providing input to regulatory documents such as IB, IND, NDA/MAA etc.
•    Proven ability to work across different functions and disciplines, along with strong project management skills
•    Fluency in English, both spoken and written 
•    Excellent communication skills to maintain contact with CROs and project/trial teams

To succeed, you thrive in an organization where the only constant is change and where you will not find manuals and SOP's for everything you do - we trust you to make the right decisions. As you will have multiple contacts internally and externally you will need an open-minded approach towards different ways of working as well as towards different cultural and professional backgrounds. You like to share knowledge and win as a team, yet you are not afraid to take lead on your own, e.g. as the department's representative in major projects.
 
Your new team
You will join the Department of Translational Sciences, where you will work with experts in bioanalysis, toxicology, pharmacokinetics, pharmacology, bioinformatics and nonclinical documentation. 
We are a mall team of highly skilled scientists at LEO Pharma's headquarters in Ballerup, Greater. We work in an informal and friendly atmosphere built on trust and mutual support.
 
Your application
Ready to take the next step in your career? Apply now to join LEO Pharma. We look forward to receiving your application!
At LEO Pharma, we believe in the power of teamwork and the potential of every individual. Join us and be part of a company that is making a real difference in the world of pharmaceuticals. Apply today and seize this incredible opportunity to build new areas in a land full of possibilities.
You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.
 
Beyond the skin
Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.

At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.

For certain positions, LEO Pharma might complete a background check conducted by a third party.
Join us on our journey Beyond the Skin. Apply today!

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