An exciting opportunity has arisen for a lead scientist to join a global pharmaceutical company in North Wales. This is a 6-month contract, and requires someone to critically and holistically review and gap assess one of their pipeline products before moving into process validation.

The Product is a biological drug substance.

Your new role summary

• Lead the process transfer of Drug Substance (DS) manufacturing process for new products from development to manufacturing.
• Ensure process knowledge and control strategies are appropriate to ensure drug substance processes operate in a reliable, cost-effective, safe, and compliant manner.
• Ensure documentation is ready and available to support the process design of drug substances ahead of regulatory examination.
• Action any identified gaps and ensure they are closed as required prior to PPQ and commercial manufacture.

Key responsibilities

• Able to interrogate process monitoring and data analysis of the DS process. Identify areas of improvement or concern.
• Presenting the review finding and proposed actions to address any gaps to stakeholders, including the Site Leadership team, BPD and the global MS&T team
• Able to perform technical/critical review of data from the drug substance process, including Upstream and Downstream steps
• Provide guidance for the remediation of any gaps in the design, optimisation and implementation of DS manufacturing processes utilising scientific principles, process, and product knowledge.
• Communicate project status to MS&T Management, TechOps Asset lead and other key stakeholders via the appropriate escalation channels and project meetings.
• Challenge and influence stakeholders to drive alignment, secure commitment, and enable successful outcomes through informed, data-driven decision-making and collaborative engagement.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.