Analytical Scientist

The Vale of Glamorgan (Bro Morgannwg)
30000.00 - 35000.00 GBP Annual
07 Aug 2017
14 Aug 2017
Contract Type
The Role
Leading a small team of analysts, the individual will take a hands-on approach to running the analytical services required to support pharmaceutical development of the company's Sustained Delivery pipeline. With an excellent knowledge of chromatography and general analytical techniques, the post-holder will lead the development and validation of new assays, oversee the daily analytical workload and grow the capabilities to complement the current and growing needs of the company. The post-holder will also take an active role in quality and compliance, particularly in the support of the company's new Pharmaceutical Development Unit.

The role will lead the delivery of expert analysis, characterization and evaluation of material and products at all stages of the development process, considering scientific and timing objectives. Working closely with cross-functional teams, the analytical team provide robust data, interpretation and advice on sustained release formulations. In-house techniques include HPLC, UPLC, LC-MS, DSC, Karl Fischer titration, microscopy and other, drug, polymer and particulate analyses. Further techniques are outsourced, with this role overseeing the management of 3rd party analytical service suppliers. The successful applicant will be familiar with these techniques and have experience of calibrating, maintaining instruments and handling raw datasheets. Familiarity with the GMP and ICH guidelines is essential.

With experience of a pharmaceutical quality environment, the post-holder will assist with compliance to quality guidelines in a pragmatic manner. Working at the interface between R&D and GMP manufacturing, the individual will be required to understand the chemical and pharmaceutical attributes of the products and ensure that the analytical techniques and quality systems keep pace with development.

The role will further include management of resources, setting and adherence to budgets and regular reporting of progress to a multi-disciplinary management team. This role will be the technical authority on analysis of SR products, combining excellent management with hands-on, goal-focused leadership of in-house and outsourced analytical resource.

Daily duties will include:
?? Leading analytical team to carry out all analytical activities required to deliver new sustained release (polymeric microspheres) in to clinical studies and beyond
?? Manage outsourced analytics
?? Lead the planning and execution of experiments to generate scientific understanding in development of analytical methods, formulations and processes
?? Applying leading-edge science to develop, validate and support in vitro and/or analytical methods
?? Processing and review data, interpret results and report experimental outcomes
?? Leading the troubleshooting of instrumentation and investigation of aberrant sample results
?? Maintain laboratory documentation in accordance with local and ICH practices
?? Work with wider multi-disciplinary team smooth and safe operation of laboratories and identify opportunities for improvements in working practices and procedures

The Candidate
?? BSc in chemistry or related subject
?? Experience in a pharmaceutical quality/analysis setting
?? Expert understanding of modern laboratory techniques, including HPLC/UPLC, MS, NMR
?? Working knowledge of GMP and pharmaceutical quality systems
?? Excellent IT skills (including Microsoft Excel, Word, PowerPoint)
?? Excellent understanding of laboratory safety and best practice
?? Excellent understanding of basic principles of physical, organic and analytical chemistry, and can demonstrate advanced knowledge in specific areas related to their experience
?? Team player
?? Able to work autonomously to deliver multiple tasks, planning own work to consistently achieve output of high quality in a timely manner
?? Proficiency in speaking, comprehending, reading and writing English

?? Experience in development and testing of sustained release pharmaceuticals, polymers and large molecule active compounds
?? Knowledge of statistics (eg T-test, ANOVA, linear regression)
?? Highly familiar with calculations used in analytical chemistry and the application of statistics
?? Experience of leading a team, managing budgets and human resource

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