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

Bachem AG; Bubendorf; On-site; CHF 120,000 - 190,000; Full time

Benefits offered by this job

Pension fund contributions (60%)

Pension Plan Plus option

Swibeco discounts

Staff restaurant

Job summary

Bachem Group in Northwestern Switzerland is investing in a new Sisslerfeld site to expand production capacity by the end of the decade. As Downstream Process Expert, you will help establish and later develop downstream manufacturing operations for API production, guiding commissioning, start-up and ongoing optimization with GMP-compliant practices.

You will lead planning and design of equipment and facilities, develop technical specifications, and collaborate with TechOps, Engineering, QA, and

Qualifications

• PhD in Chemistry, Pharmaceutical Chemistry, or related scientific discipline.
• Several years of API downstream processing experience in GMP environments.
• Experience with planning, construction, commissioning, start-up or expansion of pharmaceutical facilities.
• Knowledge of preparative chromatography, lyophilization and spray drying.
• Familiarity with regulatory requirements (ICH Q7, FDA, EMA).
• Experience with process control systems and recipe configuration.

Responsibilities

• Provide technical leadership for establishment and development of downstream API processing operations.
• Support planning and design of equipment, facilities, and production areas with technical specs.
• Develop, implement and improve GMP-compliant downstream processes.
• Prepare, review and maintain technical documentation, SOPs, risk assessments.
• Provide technical support during commissioning, start-up, operation and optimization of equipment.
• Troubleshoot process/equipment issues and drive improvements.
• Collaborate with TechOps, Engineering, QA, Operations, and Project Management.
• Support regulatory inspections and customer audits.

Skills

PhD in Chemistry

GMP experience

Downstream processing

Preparative chromatography

Lyophilization

Spray drying

ICH Q7 / FDA / EMA regulatory

Process control systems

German fluency

English fluency

Education

PhD in Chemistry

Tools

SPPS

Job description

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

Would you like to shape global Operational Readiness frameworks with us?