£45k - 70k per year
about 1 year ago
My client is a pioneering. commercial stage drug development company that uses proprietary drug delivery technology to formulate molecules with known challenges to unlock their full potential.
The Bioanalytical Manager will be 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:
- Right to work in the UK
- Life Science degree, (advantage pharmacy degree)
- At least 3 years’ experience working in a pharmaceutical GLP or cGMP environment
- Proven people management skills
- Extensive working experience with ICP, GC/MS and HPLC
- Experience with FTIR and Karl Fisher desirable
- Experience with microbiological testing would be an advantage
- Knowledge of in rapid microbial identification testing and bioburden testing techniques advantage.
- In-depth knowledge of quality control pharmaceutical cGMP & cGLP standards
- Dependable knowledge of COSHH and H&S requirements
- Excellent communication skills.