QC Senior Manager ImmunologyLondon£75,000 £85,000 per annum Our client, a cellular therapy company based in London, are currently looking to appoint a new head of...
Senior Analytical Scientist
12 month contract
Are you an experienced Analytical Scientist with strong development skills? Would you like to work for a leading pharmaceutical company?
As a Senior Analytical Scientist you will;
* Coordinate with Quality to ensure all necessary documents have been sent to the receiving site in timely manner and completed.
* Work with the CMO transfer team as required to ensure compliant and timely resolution of any issues
* Conduct method reviews to determine the appropriateness of the existing analytical methods targeted for transfer
* Remediate methods to align these with current regulatory and organisational expectations by providing hands-on laboratory support
* Conduct the validation of the analytical methods consistent with ICH and organisational expectations
* Lead the analytical method transfer (for the said products) before commencing stability trials
* Develop the stability program for formulation introduction to the markets required including regulatory input and support the third party in execution
* Develop the on-going stability program to support the products throughout the lifecycle and support CMO Quality in establishing this with the third party
* Support CMO Technical in developing the appropriate control strategy consistent with DFM principles.
* Support the overall cleaning strategy, ensuring methods for confirmation of cleaning verification are suitable for use
* Support TRB approval for each formulation being transferred, at time appropriate to the overall timeline
* Review the stability/validation data as it becomes available to provide technical oversight
* Report in a timely and accurate manner, to the regular scheduled meetings of progress and next steps.
* Ensure all actions are conducted in compliance with the QMS, TGA and OH&S requirements
* Work with other functions (e.g. production, technical, Quality, EHS etc.) and external specialists as required.
To be considered for this excellent opportunity you must have the following;
* BSc in Chemistry
* Experience in QC analysis or as an analytical team leader who is thoroughly familiar with the methods and products being transferred to the receiving site
* Deep analytical background and ability to influence/lead
* Experience in leading method development/validation/transfer for complex products
* Experience with HPLC and UPLC and demonstrated knowledge of chromatographic troubleshooting
* Experience with stability management and regulatory support
* Knowledge of Quality by Design and Risk based analytical approaches
If you have previous experience as a Development Scientist and you are interested in this opportunity in Weybridge Surrey, please apply online or send your application directly to Umul-Kulthum Ahmed at (01753589647)
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.