Primary Packaging Development Expert for Pharmaceutical Innovations
3 days ago
Company Overview
LEO Pharma is a global leader in medical dermatology, driven by innovation and a commitment to making a lasting impact on patients, colleagues, and the planet.
Salary: Estimated Annual Salary: $110,000-$140,000 depending on experience and qualifications
Job Description
We are seeking an experienced Primary Packaging Development Expert to join our team. As a key member of our cross-functional team, you will play a crucial role in ensuring the quality and safety of our full product portfolio, comprising oral, topical, parenteral, autoinjector, and aPFS products.
You will primarily support complex life cycle management activities, including new product development projects.
Your responsibilities will include:
- 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 CCS, 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 CCS for new product development and product changes
- Conduct thorough evaluations of primary packaging materials and CCS, including performance testing, stability studies, and compatibility assessments
- Establish test methods and organize testing of primary packaging materials and CCS, 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
Required Skills and Qualifications
To succeed in this role, we imagine that you have:
- A Master's degree in Chemistry, Pharmaceutical Sciences, or a related field
- A minimum of 4 years of experience in primary packaging development within the pharmaceutical industry
- In-depth knowledge of primary packaging materials, CCS, and relevant regulatory requirements (e.g., FDA, EMA)
- Experience 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
Benefits
We offer a flat organizational structure that 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.
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