Senior Analytical Scientist

Senior Analytical Scientist

Weybridge, Surrey

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.