Downstream Process Expert: API Manufacturing & Site Development

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

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.