Senior Scientist Drug Product Analysis and Stability

Location: Ballerup 2750, Denmark, Denmark 
Contract type: Permanent 
Job ID: 2844 

Would you like to engage in complex projects that challenge your skills and expand your expertise in analytical chemistry and pharmaceutical science, and be part of a professional environment that values innovation, quality, and scientific excellence? Then this is the perfect opportunity for you!

LEO Pharma is looking for a dedicated and experienced Analytical Senior Scientist to join our Products & Processes team in Ballerup, Denmark. Here you will be part of a small team that is committed to improving the lives of patients around the world. Our department is known for its great collaborative spirit. You will work alongside talented scientist and technicians who are passionate about their work and supportive of each other’s growth and success.

Your role
As a Analytical Senior Scientist, you will play a crucial role in the development and validation of analytical methods, stability studies, and regulatory submissions. 

Your responsibilities will include:

• Contribute to complex development projects and ensuring timely delivery of high-quality scientific work within your area of expertise.
• Set up and follow up on stability studies, data trending and handling OOS/OOT and SNT
• Drive deviation, change control and CAPAs
• Planning and following up on analytical work in the laboratory, including internal collaborations and with CDMO/CMOs
• Develop analytical methods, specifications, and control strategies for projects during development.
• Prepare, review, and approve documentation such as electronic labnotes, protocols, reports, analytical methods, SOPs, and work instructions.
• Write regulatory documentation for regulatory submission of IMPD, NDA, MAA, and elaborate replies to health authorities.

In addition to these primary tasks, you will also be supporting GMP and regulatory compliance, 

Who are you?

We are looking for you who can bring a collaborative attitude, innovative mind-set and passion for contributing to the development of life-changing medicines and improve patient outcomes globally.

Your qualifications:

• A Ph.D. or a Master’s degree with a focus on analytical chemistry and pharmaceutical science, or equivalent education with relevant practical experience.
• 5+ years of work experience in analytical chemistry and stability, with full knowledge of pharmaceutical industry standards and practices.
• Proven track record in method development, stability studies, and trending on stability data.
• Experience in preparing regulatory documentation and ensuring compliance with regulations.

Join a workplace that fosters a culture of trust, courage, and making a positive impact.

Contact and application
For additional information, please contact hiring Manager at +45 30491416. 

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.