You will join an exciting and innovative business who have developed and patented a novel drug delivery carrier. This drug delivery mechanism can be loaded with a range of ingredients, ranging from DNA to vitamins and proteins. They are also able to alter the design of their carrier to be polypharmaceutical, allowing several different methods for administration and timed release. The company is headquartered in the UK and has opened a new facility in Sussex to perform a range of analysis and analytical validation to support manufactured products and offer additional outsourced services.
You will be leading our clients brand new analytical validation centre, supporting a small team of scientists, supporting expansion of the size as well as being responsible for the development and implementation of analytical assays for R&D and manufacturing activities, and for achieving and maintaining ISO/IEC certification and MHRA GMP accreditation of the analytical validation centre.
The responsibilities of the Bioanalytical Manager will include:
- Leading day-to-day operations of analytical validation centre
- Management of a small team of 3 – 4 scientists
- Qualification and validation of instrumentation.
- Implementation and maintenance of robust QMS
- Development and implementation of ICP, GC/MS, HPLC, and microbiological assays
- Method transfer from analytical validation lab to manufacturing facility
- Validation of R&D data and QC results of manufacturing site
- Reporting of results to management and clients.
Key qualifications and skills:
- Life Science degree, (advantage pharmacy degree) or equivalent experience
- Extensive working experience with ICP, GC/MS and HPLC within a pharma GLP or GMP environment
- Experience with FTIR and Karl Fisher desirable
- Experience with microbiological testing would be an advantage (microbial identification testing and bioburden testing techniques)
- In-depth knowledge of quality control pharmaceutical cGMP & cGLP standards
- Dependable knowledge of COSHH and H&S requirements
- Proven people management skills.