Job Description
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 operations.
* Ability to define work plans, execute and provide technical updates to project teams.
Company:
Our client is improving people's lives and health outcomes by focusing on areas of high unmet medical need.
Location:
This role is based at our clients site in Wrexham.
Apply:
For more information, or to apply for this a Lead Process Scientistrole please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote job reference 148 356.
It is essential that applicants hold entitlement to work in the UK.
Please note:
This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
INDKA
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