Experienced Analytical Scientist - Chemical Manufacturing and Analysis

at  LEO PHARMA AS

YOUR QUALIFICATIONS

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

• MSc/PhD in Analytical Chemistry, Pharmaceutical Sciences, Engineering, or related field with a focus on small molecules.
• 5+ years of experience from lead roles in analytical development within the pharmaceutical industry, preferably related to small molecules in various stages of development.
• Experience in outsourcing and coordinating activities with CMO/CROs.
• Strong knowledge of relevant analytical techniques, such as HPLC, GC, mass spectrometry, and spectroscopic methods.
• Strong leadership and communication skills and fluent in English, both spoken and written.

As an individual, you thrive on daily variations, possess a curious and flexible mindset, and excel in problem-solving. Your pragmatic approach allows you to overcome technical challenges and find efficient solutions. You are a team-player and with adaptability and openness, you contribute to the success of our team.

ARE YOU PASSIONATE ABOUT ANALYTICAL DEVELOPMENT AND EAGER TO UTILIZE YOUR KNOWLEDGE IN THE ANALYSIS OF SMALL MOLECULES DURING DEVELOPMENT? IF SO, WE HAVE AN EXCITING OPPORTUNITY FOR YOU TO JOIN OUR DYNAMIC TEAM IN CHEMICAL MANUFACTURING AND ANALYSIS. IN THIS ROLE, YOU WILL PLAY A PIVOTAL ROLE IN SHAPING OUR ANALYTICAL DEVELOPMENT STRATEGY, DRIVING INNOVATION, AND ENSURING THE SUCCESSFUL DELIVERY OF OUR PROJECTS.

LEO Pharma has embarked on an ambitious journey to become the preferred dermatology care partner improving people’s lives around the world – and that is why we need you. As our new colleague, you will have the opportunity to impact the strategy of both the area and the development projects. You will be involved in all aspects of development, experiencing a role with daily variations, where flexibility and collaboration are key words.
In Chemical Manufacturing and Analysis, you will get the opportunity to shape the future and help people with skin diseases live more fulfilling lives by advancing the standard of care.

YOUR ROLE

You will play a crucial role in complex development projects, ensuring the timely delivery of high-quality scientific work. Collaborating closely with colleagues in drug substance and drug product development, you will define the strategy and direction for analytical development within Chemical Processes and Manufacturing, driving innovation and securing project successes. You will work closely together with our colleagues from QC for the execution of GMP analyses and with external partners during development and potentially for commercial drug substances when there is a need for support with method transfers or troubleshooting.

Key responsibilities include:

• Defining the strategy and direction for analytical development within Chemical Processes and Manufacturing, driving innovation and ensuring successful project delivery.
• Analytical Lead for drug substance development projects, including defining the analytical strategy, developing, and implementing analytical methods for drug substance, setting specifications, handling impurities, and conducting stability studies.
• Support for analytical aspects of commercial drug substances.
• Participating in CMC teams and project work, collaborating with cross-functional teams to support development projects in all stages of development.
• Staying updated with industry trends and regulatory requirements to drive continuous improvement.
• Managing the selection and oversight of contract laboratories for analytical work packages.
• Writing regulatory documentation for clinical trials and new drug applications.

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

• MSc/PhD in Analytical Chemistry, Pharmaceutical Sciences, Engineering, or related field with a focus on small molecules.
• 5+ years of experience from lead roles in analytical development within the pharmaceutical industry, preferably related to small molecules in various stages of development.
• Experience in outsourcing and coordinating activities with CMO/CROs.
• Strong knowledge of relevant analytical techniques, such as HPLC, GC, mass spectrometry, and spectroscopic methods.
• Strong leadership and communication skills and fluent in English, both spoken and written