MS&T Materials Qualification Lead

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Job Description

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.

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 assessment tools (e.g., FMEA, HACCP).
• Excellent communication and leadership skills, with the ability to work cross-functionally and manage supplier relationships.

Desirable:

• Experience in biopharmaceutical manufacturing and familiarity with emerging trends in single-use technologies.
• Knowledge of nitrosamine risk assessments and control strategies.

Empowering our people to shine

At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.

Diversity, Equality, and Inclusion

Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.

If you are interested in this opportunity, we look forward to receiving your application via our online tool!

Learn more at takedajobs.com

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