Remote Senior Manager Drug Substance Microbial Fermentation

The RFT Group; Ireland; Remote; EUR 110,000 - 140,000; Full time

Job summary

The RFT Group seeks a Senior Manager, MS&T, Drug Substance, Microbial Fermentation for a fixed-term remote role reporting to the Director, MS&T. You will lead technical transfer and scale-up for microbial DS processes and drive CMC regulatory readiness.

You will collaborate with CMOs, QA, RA CMC, and Pharmaceutical Development to ensure robust, in-control processes and successful project delivery. Requires 8+ years in pharma and an advanced degree.

Qualifications

• Advanced degree in a chemical engineering/biotech/pharma field (MSc or PhD).
• Minimum 8 years in pharma technical/manufacturing roles.
• Experience with biologics drug substance manufacturing and GMP environments.
• Proven ability to lead tech transfer projects and work with CDMOs.

Responsibilities

• Lead DS operations tech transfers and troubleshooting.
• Oversee microbial fermentation scale-up and purification tech.
• Manage changes, batch review, and deviations under GMP.
• Ensure regulatory readiness and QbD compliance across projects.

Skills

Microbial Fermentation

Tech Transfer

QbD principles

CMC regulatory

Cross-functional leadership

Education

MSc/PhD in Chemical Engineering or related

Job description

The RFT Group seeks a Senior Manager, MS&T, Drug Substance, Microbial Fermentation for a fixed-term remote role reporting to the Director, MS&T. You will lead technical transfer and scale-up for microbial DS processes and drive CMC regulatory readiness.

You will collaborate with CMOs, QA, RA CMC, and Pharmaceutical Development to ensure robust, in-control processes and successful project delivery. Requires 8+ years in pharma and an advanced degree.