Expert Primary Packaging Specialist

4 weeks ago

Ballerup, Ballerup Kommune, Denmark LEO Pharma Full time
About the Role

As a Primary Packaging Senior Specialist at LEO Pharma, you will play a crucial role in ensuring the quality and safety of our full product portfolio. Your expertise in primary packaging materials, container closure systems, and relevant regulatory requirements will be essential in supporting complex life cycle management activities and new product development projects.

Key Responsibilities:

  • Make scientific decisions regarding primary packaging materials and container closure systems based on regulatory requirements and industry best practices.
  • Establish contracts with suppliers for testing of primary packaging materials and container closure systems, ensuring compliance with quality standards and cost-effectiveness.
  • Collaborate with cross-functional teams, including Manufacturing, Development, Regulatory Affairs, and Quality Assurance, to assess and select appropriate primary packaging materials and container closure systems for new product development and product changes.
  • Conduct thorough evaluations of primary packaging materials and container closure systems, including performance testing, stability studies, and compatibility assessments.
  • Establish test methods and organize testing of primary packaging materials and container closure systems, as well as protocols, and organize extractable and leachable studies.
  • Coordinate the ordering of test materials for primary packaging, ensuring availability and timely delivery for validation and stability studies.
  • Support packaging-related investigations, root cause analysis, and CAPA activities.

About You

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

  • Masters degree in Chemistry, Pharmaceutical Sciences, or a related field.
  • Minimum of 4 years of experience in primary packaging development within the pharmaceutical industry.
  • Indepth knowledge of primary packaging materials, container closure systems, and relevant regulatory requirements.
  • Experienced in working with CDMO and CMOs.
  • Proven ability to work collaboratively in cross-functional teams and effectively communicate complex packaging concepts to stakeholders at various levels.
  • Excellent analytical and problem-solving skills, with the ability to make informed decisions based on scientific data and risk assessments.
  • Ability to prioritize and manage multiple projects simultaneously.

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