Primary Packaging Senior Specialist

at  LEO PHARMA AS

Field of work: Engineering & Manufacturing
Posting Date: 2 May 2024
Location: Ballerup 2750, Denmark, Denmark
Contract type: Permanent
Job ID: 2036
Role Description
NB: The location says Ballerup, Denmark, however job location could be all over Europe where LEO Pharma has affiliates.

YOUR QUALIFICATIONS

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

• Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field
• 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).
• 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

ARE YOU A HIGHLY MOTIVATED PROFESSIONAL WITH A PASSION FOR ENSURING THE QUALITY AND INTEGRITY OF MEDICINAL PRODUCTS AND DRUG-DEVICE COMBINATION PRODUCTS THROUGH EFFECTIVE PRIMARY PACKAGING? ARE YOU READY TO PLAY A CRUCIAL ROLE IN PRODUCT DEVELOPMENT AND LIFE CYCLE MANAGEMENT ACTIVITIES? THEN THIS IS THE PERFECT OPPORTUNITY FOR YOU!

At LEO Pharma, our mission transcends the conventional. We are on an ambitious path to become the leaders in medical dermatology worldwide. We share a “challenge accepted” mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals.

YOUR ROLE

As a Primary Packaging Senior Specialist, you will join a group of 3 Primary Packaging Specialists and play a crucial role in ensuring the quality and safety for the full product portfolio of LEO Pharma comprising oral, topical, parenterals, aPFS and autoinjector products. You will primarily support complex life cycle management activities, but new product development projects will also be part of the position.

More in detail, your activities will include:

• Make scientific decisions regarding primary packaging materials and container closure systems (CCS) 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

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

• Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field
• 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).
• 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 simultaneousl