Publicerad: 2024-11-08
Material Lead
The devices consist of several components made from different types of materials, mostly plastics. The materials used in the devices can be single-sourced, meaning they come from a single supplier at a single site. The process to replace materials is time-consuming and usually takes 2-4 years depending on the component. The aim of this work is to find second sources for most of the single-sourced materials. It will also contribute to a material strategy for the devices by implementing more dual-sourced materials for critical components to decrease supplier risks.
QRIOS Life Science is now looking for a Material Lead for a consultant assignment. The Material Lead will play a crucial role in ensuring the success of the projects through expert management of material-related activities.
About the position
The Material Lead is a key role within the project management team, responsible for overseeing all aspects related to material selection, assessment, and qualification throughout the lifecycle of a project. This role ensures that materials meet technical, regulatory, and sustainability standards, and collaborates closely with various stakeholders to ensure project success.
Responsibilities
• Conduct material selection and technical assessments for pre-studies including final decision making on candidate materials
• Ensure material compliance with sustainability, regulatory, and stability requirements.
• Conduct risk assessments for biocompatibility for new materials
• Conduct risk assessments for extractables and leachables for new materials
• Complete environmental sustainability assessments in collaboration with the Global Sustainability support function
• Develop materials qualification plans.
• Develop and approve production qualification documents.
• Plan, conduct and manage line trials for verification testing in collaboration with contract manufacturers
• Evaluate test results from contract manufacturers and provide recommendations for best candidates based on consolidation of insights gathered from historical evaluations
• Oversee biocompatibility testing processes.
• Oversee extractables and leachables testing processes.
• Gather and manage supplier documentation including material certification into a summary report
Your profile
• Bachelor's degree in Engineering, Materials Science, or a related field.
• Proven experience in material selection, assessment, and qualification including injection moulding from the pharma industry.
• Strong understanding of pharmaceutical regulatory requirements and quality standards.
• Strong understanding of sustainability requirements and a preference for skills in Life-cycle-Assessments (LCAs) and assessments for Impact to Nature.
• Excellent project management and communication skills mainly in English.
• Ability to collaborate with cross-functional teams and manage multiple stakeholders.
Key Competencies
• Technical expertise in material science and engineering.
• Strong analytical and problem-solving skills.
• Attention to detail and commitment to quality.
• Effective time management and organizational skills.
• Leadership and decision-making capabilities.
About the organisation
QRIOS Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you. Being a consultant at QRIOS gives you opportunities to try different industries, companies and roles.
It suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.
QRIOS Life Science is now looking for a Material Lead for a consultant assignment. The Material Lead will play a crucial role in ensuring the success of the projects through expert management of material-related activities.
About the position
The Material Lead is a key role within the project management team, responsible for overseeing all aspects related to material selection, assessment, and qualification throughout the lifecycle of a project. This role ensures that materials meet technical, regulatory, and sustainability standards, and collaborates closely with various stakeholders to ensure project success.
Responsibilities
• Conduct material selection and technical assessments for pre-studies including final decision making on candidate materials
• Ensure material compliance with sustainability, regulatory, and stability requirements.
• Conduct risk assessments for biocompatibility for new materials
• Conduct risk assessments for extractables and leachables for new materials
• Complete environmental sustainability assessments in collaboration with the Global Sustainability support function
• Develop materials qualification plans.
• Develop and approve production qualification documents.
• Plan, conduct and manage line trials for verification testing in collaboration with contract manufacturers
• Evaluate test results from contract manufacturers and provide recommendations for best candidates based on consolidation of insights gathered from historical evaluations
• Oversee biocompatibility testing processes.
• Oversee extractables and leachables testing processes.
• Gather and manage supplier documentation including material certification into a summary report
Your profile
• Bachelor's degree in Engineering, Materials Science, or a related field.
• Proven experience in material selection, assessment, and qualification including injection moulding from the pharma industry.
• Strong understanding of pharmaceutical regulatory requirements and quality standards.
• Strong understanding of sustainability requirements and a preference for skills in Life-cycle-Assessments (LCAs) and assessments for Impact to Nature.
• Excellent project management and communication skills mainly in English.
• Ability to collaborate with cross-functional teams and manage multiple stakeholders.
Key Competencies
• Technical expertise in material science and engineering.
• Strong analytical and problem-solving skills.
• Attention to detail and commitment to quality.
• Effective time management and organizational skills.
• Leadership and decision-making capabilities.
About the organisation
QRIOS Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you. Being a consultant at QRIOS gives you opportunities to try different industries, companies and roles.
It suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.