Pharmaceutical development is an lengthy and complex process, and ensuring the removal of impurities along with characterising the API is crucial to this. My client, a leading pharmaceutical company in the North East, is currently recruiting the high level expertise of a Solid State Manager to oversee the operations of the API characterisation team.
Solid State Manager – Key Responsibilities:
- To provide expert knowledge in solid state characterisation techniques (DSC, XRPD, TGA, DVS, microscopy, NMR, FTIR, Raman, PSD, IDR, SEM, GC and HPLC) for drug development programmes.
- To manage a team of scientists whose purpose is to investigate the solid state characteristics of materials.
- Investigate and review analytical deviations and Out of Specifications (OOS).
- As required, perform cGMP review and analytical approval of materials.
- Organise and plan calibration and maintenance of analytical equipment to meet cGMP and operational requirements.
- Manage project costs for solid state characterisation activities.
- Evaluate and purchase new technology for the characterisation of API’s, intermediates and raw materials.
- As required, develop, evaluate and prepare analytical methods, monographs, protocols and SOPs.
- Evaluate new technologies in solid state characterisation as appropriate to SPS needs.
- To support method validation programs and cGMP stability programs.
Solid State Manager – Key Requirements:
- PhD with relevant experience in the area of solid state chemistry or material science of organic substances, or related discipline
- Solid State Expert who, along with having significant project responsibility, will provide technical input in the area of material science during the characterization and the lead the team to high effect
- Experience in the characterisation and selection of active pharmaceutical ingredients
- Crystallization is advantageous, or in the area of structure-properties relationship for liquid formulation
- Experience/knowledge or a keen interest in the field of automation, simulation, prediction or design of experiments would also be advantageous.
- 5-10 years practical experience of solid state characterisation.
- Good knowledge of cGMP/GLP requirements
- Experience of analytical project planning and management
This permanent role as a Solid State Manager is an excellent opportunity for a highly qualified individual to lead and further develop a world class team in the Pharmaceutical sector, with a company that values their employees to a high extent.
Please call Charles on 01619427163 for more information.