A Pharmaceutical company is looking for a Senior Analytical Scientist to join the team on a 12-month fixed term contract. As Senior Analytical Scientist you will lead the development and characterisation of device products. You must hold a minimum of a BSc in Chemistry, or related subject, and have previous lab experience using GCMS, LCMS and spectroscopy techniques.
- Analytical technical lead in the New technologies project team, covering the development and the characterisation of device products under Development and Design Control
- Lead the technical development of analytical assays and product characterisation methods supporting device products (both in-house and through third party if required)
- Act as the Interface between R&D and Manufacturing Quality Control ensuring that the developed methods are fit for transfer into a GMP operating area and lead the method transfer from the Sending Unit (R&D)
- Work closely with the Project Leader to ensure that analytical and product characterisation method development matches the expectations based on the project design development stage and regulatory requirements
- Support the lead Project Engineer with planning and running of lab-based technology design experiments.
- Work closely with the R&D Laboratory Manager to ensure that Processes and Plant related to the product characterisation are fit for purpose and accounted for in the budget
- Write and provide direction in writing SOPs and Work Instructions required for executing characterisation techniques
- A minimum of a Bachelor of Science Degree or equivalent qualification is required. Higher degree such as PhD preferred
- Experience managing and coordinating technical programmes, generating technical data and delivering high quality reports and/or presentations of findings
- Experience working in a regulated industry, preferably medical devices and/or pharmaceutical
- Competent in chemical/physical/biological characterisation of materials and devices, investigative techniques and technical writing
- Extensive experience of LC/GC-MS, spectroscopy & microscopy techniques required
- Experience in user interface testing (Human Factor) and elution techniques strongly recommended
- Experience in rheology and fluid dynamics desired
- Knowledge of ISO13485, ICH Q1/Q2/Q3/Q8 Guidelines desired
- Experience of Third party interaction recommended
This is a great opportunity to join an international company.
Competitive salary in line with experience
12 month Fixed Term Contract
Job Ref: 5867