
Lead Process Scientist
- Wrexham
- Permanent
- Full-time
- 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 Drug Substances ahead of Regulatory examination.
- Ensure any gaps in the process design and/or control strategy are identified.
- Provide guidance for the remediation of any gaps in design, optimisation and implementation of DS manufacturing processes utilising scientific principles, process, and product knowledge.
- Hold a relevant scientific degree or have equivalent working knowledge.
- Have a broad understanding of CMC activities, regulatory strategy, understand risks and be able to link actions to Manufacturing Science and Technology.
- Able to perform technical/critical review of data from Drug substance process, including Upstream and Downstream steps.
- Excellent stakeholder management and the ability to influence and challenge.
- Knowledge of Drug Substance unit operations.
- Ability to define work plans, execute and provide technical updates to project teams.