LEO Pharma

Drug Device Scientist to team Primary Packaging in Pharmaceutical Product Support

Are you passionate about improving lives of millions of people by supporting LEO Pharma’s marketed products within biologicals and small molecules?

This is your chance to join one of the world’s leading companies within dermatology and to set your mark on the quality of life for millions of patients around the world. Global Research & Development in LEO Pharma devotes its efforts to develop innovative drugs for the treatment of skin diseases like psoriasis and eczema. You can look forward to becoming part of a team with high professional standards in an informal atmosphere where tasks vary, and not many days are alike.

Great opportunity within Primary Packaging

Pharmaceutical Product Support is part of Global R&D, counting 49 persons divided into three departments and six teams. You will be part of the Primary Pack team currently consisting of five people. You will get highly dedicated colleagues with a broad and varied expertise and experience. The team supports both the development projects and the marketed products with Life Cycle Management activities and projects. The team is responsible for preparation and maintenance of the documentation supporting the primary packaging in close collaboration with other departments.

Our values are Impact, Courage, Trust and mutual respect and helpfulness – and we care about each other.

Primary areas of responsibility:

To strengthen our capabilities within drug / device combination products and biopharmaceuticals, we are looking for you as the newest expansion to our team. You will have a key role as the primary packaging team’s representative in several development projects where you among others will be collaborating with drug - and device development, and manufacturing partners. You will be responsible for securing and documenting primary packaging quality during the technical verification phase through to launch and into the product maintenance phase.

You will be the technical expert on various development projects, and in some cases also taking on some project coordinating tasks related to your field.

Typical tasks for you will be:

  • Support development projects on drug / device combination products, primary packaging, and other packaging solutions for drug substances, drug products, intermediates, and raw materials
  • Taking scientific decisions regarding drug / device combination products and primary packaging materials e.g. provide decision scenarios and advise management groups on best way forward 
  • Analyzing complex issues and significantly improving, changing, or adapting existing processes, systems, or products
  • Establish test methods and organize testing of primary packaging materials products and act on the results
  • Write and update quality documentation (Module 3) for regulatory purposes in connection with life cycle management activities, internal projects, questions from authorities, renewals, and applications
  • Be involved in Partner, CRO, and CMO interactions, and act as task lead and technical project manager for tasks / projects running externally
  • Initiate establishment of contracts, giving input to work orders, CDAs, and other contracts
  • Ordering of test materials
  • Participate in Health Authority interactions (inspections, Q&As), if needed
  • At times participate in global, cross-organizational improvement projects across LEO Pharma

The ideal candidate:

You drive results, focusing on execution and consistently achieving results. You are interested in collaboration, to learn from and help others, give feedback and work together to deliver results. You value differences and recognize the value that different perspectives and cultures bring to an organization. Even when things are uncertain or undergoing changes, you manage ambiguity and still operate effectively.

You are expected to use appropriate behavior to secure organizational impact and influence project stakeholders.

You are comfortable with taking a broad responsibility that may even exceed the border of your specialist area. You will have the opportunity to involve yourself in adjacent areas, if you have the motivation and capabilities.

Your experience and competences:

  • Relevant Master degree qualification
  • Expert insight and knowledge within drug / device combination products, which you have been working hands-on with for 3+ years
  • Experience with biological drug products from the biopharmaceutical industry (and preferably also small molecule pharmaceutical)
  • Good experience with working under GMP, pharmacopoeias, regulatory requirements, and similar guidelines
  • Experience with physical, chemical, and functional tests such as permeability, extractables / leachables, compatibility, and tightness
  • Experience from CMC 
  • Excellent stakeholder management skills and experience in working in project teams
  • Good communication skills (English and Danish/Scandinavian)
  • Preferably LEAN / continuous improvements experience 

Contact & application:

Do not hesitate to contact Senior Manager Birthe Ross +45 72 26 35 64 if you want to know more about the position. Deadline is June 20th, 2021. Job interviews will be held on a continuous basis, also starting before the deadline. We look forward to receiving your CV and motivated cover letter.

About LEO Pharma

At LEO Pharma, we are pioneering together. We help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration and curiosity. We are at the forefront of science in developing new medicines for dermatology. Each one of us at LEO Pharma can make a real impact in our everyday work. Together, we explore new ideas and make them happen. We do this through mutual respect and a shared sense of purpose, rooted in our caring culture and a commitment to helping others. For us, pioneering together is about constantly improving and extending what’s possible for each other, our company, and our patients.

LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. In 2019, the company generated net sales of DKK 10,805 million. Read more at leo-pharma.com

 

 

Share on:

Region:

  • Region Hovedstaden
  • Region Sjælland

Job type:

Permanent

Working hours:

Full-time

Working days:

Day

Application deadline:

20/05/2021

Location:

Ballerup, Denmark

Company homepage:

http://www.leopharma.com

Office address: