Drug Product MSAT Process Specialist
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, with vital research and development functions located here. We are currently seeking a Drug Product MSAT Process Specialist for our esteemed client, F. Hoffmann-La Roche AG, in Basel.
Background:
The Drug Product MSAT Process Specialist serves as the crucial link between the PTT global MSAT team and both internal and external manufacturing sites. In this role, you will facilitate successful process industrialization by supporting during Technical Reviews, Engineering Runs, Process Performance Qualification, and launch phases. You will drive systematic process improvements tailored to product and portfolio needs, manage second source transfers, and offer hands-on support in addressing investigations, CAPAs, and troubleshooting in collaboration with local MSAT functions, Product Stewards, and Product Technical Leads.
This is a highly specialized and execution-focused position that provides essential technical support across the site network for both product-specific and multi-product demands. Your expertise may be leveraged in key technical governance forums and interactions with senior stakeholders, including the Global MSAT Leadership Team and various PTT capability teams.
Tasks & Responsibilities:
- Support Product Technical Leads and Product Stewards to ensure process industrialization, including facility fit and manufacturability, while executing process gap assessments and developing risk mitigation strategies.
- Drive systematic process enhancements and continuous technical product health improvements based on insights, encompassing second supply and change source strategies.
- Execute validated state support activities such as WCB shipments, sample coordination for additional studies, and non-routine sampling planning, ensuring compliance with evolving conditions.
- Provide technical expertise for technical and engineering runs, both internally and externally.
- Deliver hands-on second-level commercial product support in case of investigations, CAPAs, and troubleshooting, working closely with both internal and external manufacturing networks.
- Lead non-product specific root cause analyses (RCAs) and investigations on behalf of the internal manufacturing network.
- Leverage the pilot plant team to facilitate scaled experimentation supporting process-related projects and process transfers.
- Implement network initiatives aligned with manufacturing site plans.
- Incorporate and execute portfolio-wide impacting aspects such as direct material changes and Health Authority requirements.
- Perform defined technical Product Life Cycle activities to ensure product robustness throughout its lifecycle.
- Execute process-related mitigation of complaints and deployment of CAPAs across various sites or products.
- Drive technical sustainability improvements across products, processes, and technologies, including digital advancements.
- Collaborate closely with global and site functions and leadership, maintaining partnerships with E2E Product Technical Leads and DS or DP Technical Leads.
- Act as a digital enabler, translating business needs into digital strategies and collaborating with digital product development teams.
Must Haves:
- B.S. or M.S. degree in Chemical, Biochemical Engineering, or related discipline with 3+ years of relevant industrial experience in platform-specific technical process development, process engineering, or manufacturing operations; a PhD is advantageous.
- Technical Expertise: Minimum of 3 years in process engineering, technical process development, process validation, or technology transfer, with solid understanding of pharmaceutical quality systems and regulatory submission requirements.
- Outstanding Communication Skills: Advanced verbal and written communication abilities, including the capacity to articulate team deliverables to senior leadership. Fluency in English is required; proficiency in German is a plus.
- Willingness to travel up to 10% as needed.
What You Will Be Offered:
- An opportunity to contribute to one of the world's leading pharmaceutical companies.
- A modern campus featuring abundant green spaces and collaborative meeting areas.
- Central location in Basel.
- A diverse job profile that offers continual professional growth.
- Further training opportunities through temptraining.
- Work alongside a dynamic and motivated team.
If you are interested, please apply online using the form below. Only applications matching the job profile will be considered.