Principal Primary Packaging Scientist to Pharmaceutical Product Support
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Ballerup
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 and 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 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
You will have a key role as the primary packaging team’s representative in several development and maintenance projects where you among others will be collaborating with drug / 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.
Our development projects are run by close stakeholders, and besides being the technical expert, you will also be given the responsibility for some project coordinating tasks, in order to support the development projects.
Typical tasks for you will be:
- Support development projects and life cycle management activities on primary packaging, drug device combination products, and other packaging solutions for drug substances, drug products, intermediates, and raw materials
- Analyzing complex issues and significantly improving, changing or adapting existing processes, systems or products.
- Scientific decisions regarding primary packaging materials and drug / device combination products
- Provide decision scenarios and advise management groups on best way forward in matters regarding primary packaging
- Establish test methods and organize testing of primary packaging materials and drug / device combination 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
- Participate in Health Authority interactions (inspections, Q&As)
- Ordering of test materials 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.
As a specialist, 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
- You have a strong scientific background within pharmaceutical sciences, chemical engineering, device engineering, or related fields
- Experience with biological drug products from biopharmaceutical (and preferably also small molecule pharmaceutical) industry
- Expert insight and knowledge within primary packaging and drug / device combination products or a related area, e.g. food industry
- 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
- Solid CMC knowledge
- Excellent stakeholder management skills and experience in working in project teams
- Good communication skills (English and Danish/Scandinavian)
- Preferably LEAN experience or experience with continuous improvements
Contact & application
Do not hesitate to contact Senior Manager Thomas Groth +45 3122 4079 if you want to know more about the position.
Deadline is January 4th 2021. Job interviews will be held on a continuous basis, also starting before the deadline.
We look forward to receiving your motivated application.
Information og data
Denne ledige stilling har jobtypen "Lagermedarbejder", og befinder sig i kategorien "Industri, håndværk og teknik".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 13.11.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Lagermedarbejder
- Ballerup
- Mandag den 04. januar 2021
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