Are you a talented analytical scientist with experience leading external stability studies?
Would you like to work for a global clinical-stage biotechnology company in the Oxfordshire area?
Working for a global biotechnology company, you will play a key role in the planning and reporting of stability studies performed at external contract manufacturing organisations. You will be supporting the advancement of the company's product pipe line in adherence to their QMS.
* Manage external stability studies at CDMO's. Planning, co-ordination, and day-to-day performance of external stability studies
* Champion and pro-actively evolve the GMP and Quality driven processes for ensuring data integrity of results being generated and reported from the Quality Control functional area
* Manage the compilation of QC testing metrics to drive method and quality improvements
* Identify and report method remediation requirements cross-functionally to analytical subject matter experts
* Competent to perform and train Quality Control team members in the portfolio of analytical stability test methods
To be considered for this excellent opportunity you MUST have the following;
* Proven experience of analytical method Quality Control testing and working to GMP compliance
* Extensive knowledge and experience of stability study design, testing requirements, quality checking, setting acceptance criteria and method performance controls, managing investigations and writing reports
* Excellent understanding of stability and related ICH / other regulatory guidelines
* Knowledge of bioassays, biopharmaceutical assays, statistical evaluation of assay variability
* Understanding of analytical requirements to support clinical and commercial products
* Knowledge of method validation requirements to demonstrate stability indicating capabilities
There are a number of exciting projects currently on-going and my client is looking for Senior Scientist who want to work in a varied role managing several projects as well as supporting the development of new products. In return you will receive excellent training, a competitive salary and a fantastic amount of experience due to exposure to wide number of projects.
If you feel you have the right skills and experience for this role please apply online or call Suhel Uddin on 0121 728 8452 for further information
You must be eligible to work in the UK. Learn more
- Agency: SRG
- Reference: J2161038
- Posted: 9th July 2021
- Expires: 6th August 2021