Global MSAT DS Senior Process Steward 80-100%

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La position Pharma Technical Technology (PTT) within Pharma Technical Operations (PT) is dedicated to enhancing industrialization and product management. This is achieved through the integration of Safety, Health, and Environment (SHE) standards, maintenance excellence, performance optimization, and the establishment of scalable processes to improve overall robustness, efficiency, and reliability across the organization.

The global Manufacturing Science and Technology (MSAT) function manages commercial products, spearheads the adoption of new technologies, drives standardization efforts, and ensures risk mitigation. The Opportunity The organization is structured into specialized teams focusing on Large Molecule Drug Substance (DS) and Drug Product (DP), and Small Molecule operations. This particular role, the Global MSAT DS Senior Process Steward, operates within the Large Molecule DS team and is crucial for connecting global MSAT expertise with manufacturing sites worldwide.

• Support Product Technical Leads and Product Stewards to ensure process industrialization, coordinate and execute process gap assessments, integrate identified risks into the risk log, and develop mitigation strategies.
• Drive systematic process and continuous technical product health and supply improvements based on insights, including second source and change strategies.
• Execute validated state support activities and respond to evolving conditions to ensure compliance (e.g., VICs, RCAs).
• Provide technical expertise for technical and engineering runs and hands-on second-level support for investigations, CAPAs, and troubleshooting in partnership with the internal and external manufacturing network; lead non-product specific RCAs and investigations.
• Leverage the pilot plant team for real-life and scaled experimentation to support process-related projects, including validation studies and process transfer to manufacturing sites.
• Ensure the implementation of network initiatives that are aligned and prioritized with manufacturing site plans, and incorporate portfolio-wide impacting aspects like direct material changes and Health Authority requirements.
• Collaborate closely with global and site functions, leadership, and other gMSAT and PTT teams. Serve as a digital enabler, translating business needs to digital strategy and digital product development teams and driving technical sustainability improvements for product, process, and technology. Who You Are
• B.S. or M.S. degree in Chemical, Biochemical Engineering, or a related discipline with 7+ years of relevant industrial experience in process development, process engineering, or manufacturing operations; a PhD is advantageous.
• Experience in collaborative, matrix team leadership and decision-making.
• Demonstrated experience in process engineering, technical process development, process validation, or technology transfer (E. coli & CHO processes). Deep expertise in E. coli systems is strongly preferred.
• Familiarity with pharmaceutical quality systems, industry guidelines, regulatory submission, health authority requirements, and platform-specific technology, processes, and equipment.
• Advanced verbal and written communication skills, with the ability to define and articulate team deliverables effectively, including towards senior leadership, and a willingness to travel less than 10% as required. Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity! Qui nous sommes Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial. Construisons ensemble un avenir plus sain. Roche est un employeur offrant l'équité en matière d'emploi.