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)
• Multi-year experience in API downstream processing within a GMP-regulated environment
• Deep knowledge of preparative chromatography, freeze-drying, and spray drying
• Strong understanding of chemical process engineering and regulatory requirements (e.g., ICH Q7, FDA, EMA)
• Proficiency in German and English (written and spoken)
• Experience with process control systems and recipe creation

Preferred Qualifications

• Experience in the setup or expansion of production sites
• Knowledge of Solid Phase Peptide Synthesis (SPPS)
• Strong project management and communication skills

Benefits

• Opportunity to play a significant role in a major capacity expansion project
• Challenging work in a dynamic, rapidly growing environment
• A diverse and multicultural working atmosphere

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.