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

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

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