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Ms&t Materials Qualification Lead
vor 2 Wochen
Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?**
**_ OBJECTIVES/PURPOSE: _**
- Lead the qualification of all materials used in GMP manufacturing processes, including both traditional materials (chemicals, biologics, ppm) and single-use systems (SUS), ensuring compliance with regulatory standards.
- Develop and implement robust material qualification protocols, with a focus on extractables, leachables, and material compatibility to ensure product safety and integrity.
- Collaborate cross-functionally with internal teams (e.g., QC, QA, MSAT Drug Substance/Drug Product, Regulatory Affairs) and external suppliers to ensure successful material qualification.
- Drive continuous improvement and risk mitigation strategies in material qualification and supply derisking, including the integration of Nitrosamine and PFAS risk assessments.
**_ OBJECTIVES/PURPOSE: _**
- Lead the qualification of all materials used in GMP manufacturing processes, including both traditional materials (chemicals, biologics, ppm) and single-use systems (SUS), ensuring compliance with regulatory standards.
- Develop and implement robust material qualification protocols, with a focus on extractables, leachables, and material compatibility to ensure product safety and integrity.
- Collaborate cross-functionally with internal teams (e.g., QC, QA, MSAT Drug Substance/Drug Product, Regulatory Affairs) and external suppliers to ensure successful material qualification.
- Drive continuous improvement and risk mitigation strategies in material qualification and supply derisking, including the integration of Nitrosamine and PFAS risk assessments.
**_ ACCOUNTABILITIES: _**
- Lead the development and management of material specifications for traditional materials, SUS materials and primary packaging, ensuring alignment with process and regulatory needs.
- Oversee the functional testing of materials in production settings, including performance validation of SUS components such as bioreactor bags, filters, and connectors.
- Manage the materials qualification process, focusing on extractables/leachables (E&L) studies, material compatibility, and sterilization integrity.
- Collaborate with suppliers via Takeda supply teams and perform assessments as necessary to verify material compliance and handle change notifications (VCN).
- Ensure regulatory adherence (FDA, EMA, ICH) and maintain GMP compliance for all qualification activities, including documentation and risk assessments (e.g. Nitrosamine, PFAS).
- Drive risk-based approaches, including FMEA or HACCP, to assess and mitigate risks for traditional and SUS materials including supply risks.
- Work closely with internal teams to ensure cross-functional alignment and successful implementation of material qualification protocols.
**_ DIMENSIONS AND ASPECTS:_**
**Technical/Functional (Line) Expertise**
- Extensive knowledge in material characterization, E&L studies, and material compatibility for traditional materials, SUS and primary packaging materials.
- Expertise in regulatory compliance related to material qualification (FDA, EMA, ICH), including GMP documentation and risk management.
**Leadership**
- Ability to lead cross-functional projects and collaborate with internal and external stakeholders to drive material qualification efforts.
- Strategic thinking to align material qualification processes with broader organizational and regulatory goals.
**Decision-making and Autonomy**
- Autonomy in making material qualification decisions, with authority to lead risk-based assessments and mitigation strategies.
- Responsible for managing complex decision-making processes related to material performance, compatibility, and regulatory compliance.
**Interaction**
- Engages regularly with internal stakeholders, including MSAT teams, QA, QC, Regulatory, and suppliers, to ensure materials are qualified to meet process needs.
- Collaborates with external suppliers to manage material supply, performance, and change management.
**Innovation**
- Embraces new technologies and approaches for material qualification, especially for SUS and primary packaging.
- Encourages continuous improvement and innovation in material testing, qualification protocols, and risk mitigation strategies.
**Complexity**
- Oversees a diverse array of materials, including traditional materials, single-use systems (SUS), and primary packaging, across various product types and manufacturing processes.
- Navigates complex regulatory environments and cultural considerations when dealing with global suppliers and stakeholders.
**_ EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_**
- Essential:_
- Bachelor's degree in engineering, life sciences, or a related field (advanced degree preferred).
- 5+ years of experience in GMP manufacturing, with specific expertise in material qualification, SUS, and regulatory compliance.
- Strong analytical skills with experience in risk a
