Global MSAT DS Senior Process Steward 80-100%

F. Hoffmann-La Roche AG; Basel; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

Roche is seeking a Global MSAT DS Senior Process Steward to connect global MSAT expertise with manufacturing sites worldwide, focusing on Large Molecule DS. You will support process industrialization, coordinate risk assessments, and drive mitigation strategies across the network.

The role requires 7+ years in process development/engineering, with deep E. coli expertise, plus familiarity with quality systems and regulatory requirements. Travel less than 10% is expected.

Qualifikationen

• 7+ years of relevant industrial experience in process development, process engineering, or manufacturing operations.
• Experience in collaborative, matrix team leadership and decision‑making.
• Deep expertise in E. coli systems; familiarity with pharmaceutical quality systems and regulatory requirements.

Aufgaben

• Connect global MSAT expertise with manufacturing sites worldwide and coordinate process gap assessments.
• Develop mitigation strategies and drive process health, supply improvements, including second source and change strategies.
• Provide hands‑on support for investigations, CAPAs, and technology transfer; enable digital strategies and product sustainability improvements.

Kenntnisse

Process development

Process engineering

Technology transfer

E. coli systems

Regulatory awareness

Ausbildung

B.S./M.S. in Chemical/Biochemical Engineering

PhD (advantageous)

Jobbeschreibung

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. The 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.

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life‑changing healthcare solutions that make a global impact. Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.

We believe it's urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.