CMO Process Specialist (Biotechnology, Remote)

Job summary

The CMO Process Specialist plays a vital role in optimizing production processes and ensuring product quality within a global context. This position involves collaboration with internal manufacturing teams and external Contract Manufacturing Organizations (CMOs) to address deviations and enhance operational excellence.

Qualifications

• Bachelor’s or Master’s degree in Biotechnology, Microbiology, Biochemistry, or a related discipline
• Recent graduates or candidates with a few years of experience in biotechnology or production environments
• Strong interest in production processes and operational excellence
• Fluent in English, both written and spoken

Responsibilities

• Monitor CMO product quality performance and implement corrective and preventive actions
• Address deviations and complaints related to CMO production
• Conduct troubleshooting on the shop floor to identify root causes and establish sustainable solutions
• Support process optimization initiatives when product quality falls short of expectations
• Serve as a key liaison between internal manufacturing and external CMOs to ensure alignment and knowledge transfer

Skills

• Experience in international or global manufacturing environments is advantageous
• Familiarity with CMOs or external production partners is beneficial
• Knowledge of fermentation, cultures, or biological production processes is a plus
• Additional language skills beyond English are considered an asset

Education

• Bachelor’s or Master’s degree in a relevant field

Tools

• Proficiency in production-related tools and methodologies relevant to biotechnology and operational excellence