Principal Scientist, Primary Packaging for Devices and Injectables

Application deadline: 30-April-2025 
Location: Ballerup , , Denmark 
Contract type: Permanent 
Job ID: 3032 

Do you thrive in a collaborative environment and are dedicated to being an expert? Would you like to drive development and knowledge sharing within the team? Are you open to challenges and like to have an impact?

Shape the LEO Pharma of tomorrow
At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide. If you're ready to lead with passion and expertise, this role is your gateway to a world of opportunities!
In Application Management TDS & Corporate we share a "challenge accepted" mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals.

Your role
As part of a team that works cross-functionally, you will play a crucial role in managing primary pack devices, ensuring compliance with current regulations and guidelines. Your expertise in risk assessment will be vital as you lead complex projects and tasks, providing mentorship and reviewing the work of others to help them grow. Working closely with other disciplines, you will have a great decision-making authority, contributing to the overall success and innovation of the organization.

Your key responsibilities will include
•    Scientific decisions regarding primary packaging materials and container closure systems (CCS) for injectables and drug device combination products   
•    Establish test methods or organize testing of primary packaging materials and CCS and act on the results.
•    Release testing for device tests e.g. container closure integrity 
•    Up to date on current regulations e.g. REACH 
•    Ability to evaluate and manage changes related to packaging components
•    Understanding of regulatory requirements for packaging materials and ensuring compliance with regional standards (e.g., EMA, FDA)
•    Act as task lead and technical project manager for tasks / projects running at CMO’s / CRO’s 
•    Analyzing complex issues and significantly improving, changing or adapting existing processes, systems or products
 

Your Qualifications

To succeed in this role, we imagine that you have the following qualification background:
•    A scientific degree in fields such as pharmaceuticals, chemistry, or biotechnology. 
•    At least 7 years of experience working with small molecules and/or biologics  
•    Experience in primary pack for device combination products
•    Proven expertise in defining strategy for Extractable & Leachable assessments, with the ability to evaluate the landscape and make informed decisions based on diverse inputs
•    Proven track record in risk assessment related to primary packaging, including nitrosamine and elemental impurity concerns
•    Familiarity with subcutaneous administration routes and the packaging considerations for these forms
•    Proven track record in writing and maintaining regulatory submission documents related to packaging (including responses to Health Authority inquiries)
•    Previous experience in working with CDMO's would be advantageous

Your Team
The Drug Device Combination Products (DDCP) team is part of Product and Process Technology (P&PT) in LEO Pharma. The DDCP team provides "end to end" technical and scientific support to externally manufactured DDCP’s & Primary Packaging expertise to the whole LEO Pharma portfolio.

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!

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 believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions, foster an inclusive culture, and meet the needs of the market we operate in. Therefore, we encourage you to apply for the position if you are excited about the role – even if you don’t meet every single requirement listed, you might be just the pioneer we are looking for. We believe in flexibility in all aspects - also when it comes to supporting our employees' diverse needs, hence, we offer hybrid work opportunities whenever possible.

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