Director of Drug Substance Operations

Head of Drug Substance Operations

Contract - Until end of 2025 (Outside IR35)

Our client is a clinical stage biopharma company focusing on rare diseases. They have a product which has positive results from clinical trials and require support in the UK to oversee the start of manufacturing.

This role will be the boots on the ground in the UK for this US based company. The role will require to review all process and documents whilst reporting back results to the team across the pond.

You will be required on site at their CDMOs facility 40-50% of the time initially. After Q1 2025 this will reduce to complete more documentation reviews.

Duties include

• Overseeing the manufacturing process to ensure the CDMO is performing accordingly
• Review documentation on behalf of the Global Tech Ops team
• Ensure compliance is maintained throughout the manufacturing process

Skills and Experiences

• Biologics manufacturing experience is essential
• Ability to work alone in the UK and report into the US based team
• Microbial process experience
• Can be on-site in Billingham 3-4 days per week initially