Specialist Direct Materials

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.

Join Roche, where every voice matters.

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

The Pharma Technical Operations (PT) Global MSAT & Engineering (PTT) group takes bold steps to modernize technical operations to enable Roche to deliver medicines for patients more quickly, efficiently and reliably. PTT shapes and accelerates technology innovation and product lifecycle management for tomorrow, while standardizing and driving operational excellence in PT today.

The PTT Direct Materials Specification Team owns and creates direct material specifications providing technical input, including analytical expertise, and implementing solutions to support direct materials and distribution networks. This team has the capability to flow across the direct materials lifecycle to ensure a robust and flexible supply chain for direct materials from a compliance perspective to support Product Health of our products.

The PTT Direct Materials Specification Specialist, reporting to the PTT Direct Materials Specification Lead, is responsible for modernizing materials and their application to the technical issues in PT. Partnering with key stakeholders this position is responsible for the setting, content and document management of supplier and internal release specifications of Direct Materials for Biologics and Synthetic Molecules. This also includes identification and definition of fit-for-purpose material attributes in alignment with product owners and QC.

This position requires innovative, efficient, and sustainable technical solutions supporting materials to deliver processes that enable distribution of healthy products for future-ready PT across product lifecycle.

• Accountable for the content of Direct Material Specifications in collaboration with the PTT Material Science team, along with input from internal and external stakeholders to establish global and fit for use specifications, including materials used by cell and gene therapy and devices
• Drives global standardization of direct material specifications
• Involved in complex negotiations with internal and external stakeholders related to direct material topics to ensure fit for purpose solutions
• Responsible for building collaborations and work relationships between the team members, stakeholders and user groups:
  External Quality, Procurement, Planning, QC, QA, Manufacturing, Development, and Regulatory
• Maintains a state of inspection readiness at all times
• Responsible for owning and/or assessing deviations/changes in alignment with Quality groups

• Bachelor degree or Master degree in Science or Engineering related fields
• 4 years of experience in the pharmaceutical, biopharmaceutical, or medical device industry, or an equivalent combination of education; experience in regulatory filings and/or material specifications is an advantage
• Experience working in/leading teams in a global setting
• Working knowledge of cell and/or gene therapy materials
• Must possess project management skills with working knowledge of ICH guidelines, ISO standards or other international standards, Pharma GMP operations, and Health Authorities regulations
• Ability to interpret and follow Roche Quality standards, with knowledge of and experience using Quality Systems such as CAPAs and Change Management
• Strong quality mindset with attention to detail, delivery of service excellence, and ability to build connections, encourage feedback, and foster a collaborative environment (