Downstream API Process Lead – New Swiss Site Development

Bachem Holding AG; Lavamünd; Vor Ort; EUR 159.000 - 201.000; Vollzeit

Benefits dieser Stelle

Global exposure across operations

Internal development opportunities

Pension plan support (60% of pension)

Zusammenfassung

Bachem Group is investing in a new planned site in Sisslerfeld, Switzerland, to expand API production. The Downstream Process Expert will lead downstream operations, oversee design and commissioning, and drive continuous improvement for GMP-compliant processes.

This role offers technical ownership and the chance to shape the future site and organization during the project phase. You will collaborate across TechOps, Engineering, QA, Operations and Project Management, contributing to regulatory

Qualifikationen

• PhD in Chemistry or related field, GMP-regulated API experience preferred.
• Experience in downstream processing, planning, commissioning, or expansion of pharmaceutical facilities.
• Knowledge of preparative chromatography, lyophilization and spray drying is beneficial.
• Strong knowledge of regulatory requirements (ICH Q7, FDA, EMA) and process control systems.

Aufgaben

• Provide technical leadership for downstream processing setup and development of API manufacturing.
• Plan and design manufacturing equipment, facilities, and production areas with technical specifications.
• Develop and improve GMP-compliant downstream processes.
• Maintain technical documentation, SOPs and risk assessments.
• Support commissioning, start-up, operation, and optimization of equipment and processes.
• Collaborate with TechOps, Engineering, QA, Operations and Project Management.
• Support regulatory inspections and audits and contribute to excellence initiatives.

Kenntnisse

GMP experience

Project management

Process engineering

German and English fluency

Ausbildung

PhD in Chemistry, Pharmaceutical Chemistry, or related field

Jobbeschreibung

Bachem Group is investing in a new planned site in Sisslerfeld, Switzerland, to expand API production. The Downstream Process Expert will lead downstream operations, oversee design and commissioning, and drive continuous improvement for GMP-compliant processes.

This role offers technical ownership and the chance to shape the future site and organization during the project phase. You will collaborate across TechOps, Engineering, QA, Operations and Project Management, contributing to regulatory