CK Group are recruiting for a Lead Process Scientist to join a leading biopharmaceutical company on a contract basis for 6 months.

Salary: £193.56 per day PAYE or £250 per day via umbrella or Ltd company. This role has been assessed as outside IR35.

Lead Process Scientist Role:

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.Your Background:

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 oper...