Drug Product MSAT Process Specialist
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, with essential research and development functions located here. We are currently seeking a highly skilled Drug Product MSAT Process Specialist for our long-term client, F. Hoffmann-La Roche AG, located in Basel.
Background:
The Drug Product MSAT Process Specialist serves as the primary connector between PTT global MSAT and both internal and external manufacturing sites. This role is pivotal in facilitating successful process industrialization by providing support during tech transfers (TRs), engineering runs (ERs), process performance qualification (PPQ), and product launch phases. You will drive systematic process improvements that align with product and portfolio needs, oversee second source transfers, and deliver hands-on second-level commercial product support in collaboration with local MSAT functions and PTT Product Stewards and Technical Leads.
This is a highly specialized and execution-oriented position, where you will provide technical support across the site network, addressing both product-specific and multi-product requirements. You may also represent the technological needs of the network in key technical governance forums and engagements with senior stakeholders, including the Global MSAT Leadership Team, PTT capability teams, Manufacturing Site Leadership Teams, and other leadership teams.
Tasks & Responsibilities:
- Support Product Technical Leads and Stewards in ensuring seamless process industrialization, coordinating process gap assessments, and integrating identified risks into the risk log.
- Drive continuous technical product health and supply improvements based on insights, including second supply and change source strategies.
- Execute validated state support activities, such as WCB shipments and sample coordination for additional studies, ensuring compliance with evolving conditions.
- Provide technical expertise during technical and engineering runs, both internally and externally.
- Deliver hands-on second-level commercial product support during investigations, CAPAs, and troubleshooting in collaboration with the manufacturing network.
- Lead non-product specific root cause analyses (RCAs) and investigations on behalf of the internal manufacturing network.
- Utilize the pilot plant team for real-life experimentation to support process-related projects and transfers to manufacturing sites.
- Ensure alignment and prioritization of network initiatives with manufacturing site plans.
- Incorporate portfolio-wide impacting aspects, including direct material changes and health authority requirements.
- Perform defined technical Product Life Cycle activities to ensure product robustness throughout its lifecycle.
- Engage in the mitigation of complaints and deployment of CAPAs across multiple sites or products.
- Drive technical sustainability improvements for products, processes, and technologies, including digital advancements.
- Collaborate closely with global and site functions, including other gMSAT and PTT teams.
- Act as a digital enabler, translating business needs into digital strategies and development initiatives.
Must Haves:
- B.S. or M.S. degree in Chemical, Biochemical Engineering, or a related discipline with 3+ years of relevant industrial experience in technical process development, process engineering, or manufacturing operations. A PhD is a plus.
- Technical Expertise: 3+ years of demonstrated experience in process engineering, validation, or technology transfer, with knowledge of pharmaceutical quality systems.
- Outstanding Communicator: Excellent verbal and written communication skills, with fluency in English; proficiency in German is an advantage.
- Willingness to travel (approximately 10%).
What You Will Be Offered:
- An opportunity to work with one of the world's leading pharmaceutical companies.
- A modern campus featuring ample green spaces and collaborative meeting areas.
- A central location in Basel.
- A varied job profile with diverse responsibilities.
- Further training opportunities through temptraining.
- The chance to work within a dynamic and motivated team.
If you are interested, please apply online using the form below. Please note that only applications matching the job profile will be considered.