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

Bachem Holding AG; Stein; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Pension contributions 60%

Staff restaurant

Swibeco discounts

Internal training opportunities

Sports facilities

Campus activities

Zusammenfassung

Bachem Group is developing a new Sisslerfeld site in Northwestern Switzerland. The Downstream Process Expert will lead downstream API manufacturing setup, design, and commissioning, ensuring GMP-compliant implementation and ongoing process optimization.

In this role you will collaborate with TechOps, Engineering, QA, and Project Management to deliver a scalable, compliant, and efficient manufacturing solution for API production at the Sisslerfeld site.

Qualifikationen

• PhD in Chemistry or related field.
• Several years of GMP API downstream processing experience.
• Experience in planning and commissioning pharma facilities.
• Knowledge of preparative chromatography, lyophilization, and spray drying.
• Strong regulatory knowledge (ICH Q7, FDA, EMA).
• Fluency in German and English, written and spoken.

Aufgaben

• Provide technical leadership for establishing downstream operations in API manufacturing.
• Plan, design, and specify manufacturing equipment and facilities.
• Develop and improve GMP-compliant downstream processes.
• Prepare, review, and maintain tech docs, SOPs, and risk assessments.
• Support commissioning, start-up, operation and optimization of equipment.
• Troubleshoot process- and equipment-related issues and drive improvements.
• Collaborate with TechOps, Engineering, QA, Operations, and PM.
• Support regulatory inspections and customer audits; contribute to excellence initiatives.

Kenntnisse

PhD in Chemistry

API downstream processing

GMP experience

Project management

Communication skills

German & English fluency

Ausbildung

PhD in Chemistry or related

Tools

SPPS knowledge

Process engineering software

Jobbeschreibung

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 designphase 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.

• 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 visibility and the opportunity to shape groupwide innovation long-term.
• A dynamic and rapidly growing work environment with internal development opportunities
• Employee development through numerous internal and external training opportunities
• 60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus
• Access to the Swibeco benefits platform with discounts from external partners
• Fresh, healthy and varied food in our staff restaurant
• A wide range of free sports activities on the Bachem Campus