Downstream Process Expert - API Production Sisslerfeld Site Development (a) 100%

The Bachem Group is investing in a new planned site in Sisslerfeld in Northwestern Switzerland. This step is part of the long-term strategy to expand production capacity by the end of the decade. The new production site will play a central role in achieving these goals. The design phase of the project offers you unique opportunities to shape the future organization. As Downstream Process Expert - API Production Sisslerfeld Site Development (a) 100% , you will play a key technical role in establishing and later developing downstream manufacturing operations for API production. During the project phase, you will support the planning, design, commissioning, and start-up of manufacturing facilities and processes, ensuring GMP-compliant implementation. Once operations are established, you will take technical ownership of downstream processes and drive their continuous improvement and operational excellence. Your tasks Provide technical leadership for the establishment, commissioning, and further development of downstream processing operations for API manufacturing Support the planning and design of manufacturing equipment, facilities, and production areas, including the development of technical specifications and process concepts Develop, implement, and continuously improve GMP-compliant downstream manufacturing processes Prepare, review, and maintain technical documentation, SOPs, and risk assessments Provide technical support during commissioning, start-up, and the operation and optimization of manufacturing equipment and processes Troubleshoot process- and equipment-related issues and drive sustainable improvement measures Collaborate closely with TechOps, Engineering, QA, Operations, and Project Management Support regulatory inspections and customer audits and contribute to operational excellence initiatives Your profile PhD in Chemistry, Pharmaceutical Chemistry, or a related scientific discipline Several years of experience in API downstream processing within a GMP-regulated environment; knowledge of SPPS is an advantage Experience in the planning, construction, commissioning, start-up, or expansion of pharmaceutical manufacturing facilities In-depth knowledge of preparative chromatography, lyophilization and spray drying Strong knowledge of chemical process engineering, equipment and facility design, and relevant regulatory requirements, including ICH Q7, FDA, and EMA Experience with process control systems and recipe configuration Strong technical affinity combined with a structured, solution-oriented approach to complex engineering challenges Excellent communication, stakeholder management, and project management skills, with fluency in German and English, both written and spoken Our offer: The role offers broad exposure across global Technical Operations and Innovation Platforms and close collaboration with senior stakeholders, enabling strong professional…