Downstream Process Expert - API Production

Responsibilities

• Take technical responsibility for the setup and commissioning of downstream processes for API production at the new Sisslerfeld site
• Support the planning and design of production facilities and areas
• Develop and implement GMP-compliant downstream processes
• Create specifications, concepts, technical documents, SOPs, and risk analyses
• Collaborate closely with TechOps, Engineering, QA, and Project Management
• Support regulatory inspections and customer audits during the setup and startup phases

Requirements

• Degree in Chemistry, Pharmaceutical Chemistry, or a related field (PhD preferred)
• Extensive experience in downstream processing of APIs within a GMP-regulated environment
• Deep knowledge of preparative chromatography, freeze-drying, and spray-drying
• Strong understanding of chemical process engineering and plant planning
• Knowledge of regulatory requirements such as ICH Q7, FDA, and EMA
• Proficiency in both German and English (written and spoken)
• Experience with process control systems and recipe creation is a plus

Preferred Qualifications

• Experience in the setup or expansion of production sites
• Knowledge of Solid Phase Peptide Synthesis (SPPS)

Benefits

• Opportunity to play a significant role in a major capacity expansion project
• Challenging work within a dynamic and rapidly growing environment
• A position that offers long-term impact on the company and the region

About the Company

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of expertise, Bachem provides products for research, clinical development, and commercial applications to pharmaceutical and biotech companies worldwide.