An exciting opportunity has arisen for a lead scientist to join a global pharmaceuticalpany 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
1. Lead the process transfer of Drug Substance (DS) manufacturing process for new products from development to manufacturing.
2. Ensure process knowledge and control strategies are appropriate to ensure drug substance processes operate in a reliable, cost-effective, safe, andpliant manner.
3. Ensure documentation is ready and available to support the process design of drug substances ahead of regulatory examination.
4. Action any identified gaps and ensure they are closed as required prior to PPQ andmercial manufacture.
Key responsibilities
5. Able to interrogate process monitoring and data analysis of the DS process. Identify areas of improvement or concern.
6. 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
7. Able to perform technical/critical review of data from the drug substance process, including Upstream and Downstream steps
8. 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.
9. Challenge and influence stakeholders to drive alignment, securemitment, and enable successful oues through informed, data-driven decision-making and collaborative engagement.