To support the Analytical R&D portfolio using a broad range of separation, spectroscopy and detection techniques to deliver analytical methodology capable of operating in development and manufacturing environments.
- Works closely with analytical experts and project teams to provide timely support for chemists and formulators in the form of quality data which can be used in support of regulatory documentation (e.g. new drug applications).
- Independently carries out all aspects of practical work necessary to provide right-first-time quality results for project teams including data review activities.
- Works with colleagues and subject matter experts to assess the most appropriate analytical tools to support project activities and maintains a focus on timely delivery to the agreed project and corporate milestones. Plans and reviews own work schedules to meet deadlines.
- Provides exemplary analytical support to projects, including, for example, development of a methodology for and testing of in-process control samples, intermediates and API as well as excipient, packaging component testing, stability samples, finished bulk and packaged drug products.
- Assists in the maintenance and renewal of laboratory instruments, systems or apparatus and in the maintenance and continuous improvement of safe and effective working practices.
- Maintains written records of all experimental work in accordance with GLP/GMP and departmental philosophies.
- Maintains a contemporary awareness of Global Business Practices, methods, specifications, SOPs, Pharmacopoeial trends, ICH guidelines and regulatory expectations.
- Shows supportive leader behaviours and is a positive advocate for new technology, process improvements and informatics initiatives designed to increase efficiency and compliance.
- Direct supervision is not an envisaged part of the role but it is expected that the successful candidate will be capable of organising and planning his/her own work to achieve consistently right-first-time high-quality results.
Qualifications, Experience and Skills
- A minimum of a honours degree or equivalent in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or a related discipline is essential.
- A Masters Degree and/ or relevant work experience in a pharmaceutical laboratory based role, ideally a chemistry or analytical laboratory, or related environment is desirable.
- Comfortable working as part of multi-disciplinary, cross-functional teams is essential.
- A strong desire to develop their own technical skill set is essential.
- Good knowledge of fundamental organic chemistry, functional group recognition and compound characterisation with some experience using spectroscopic and chromatographic techniques is essential.
- Good lab safety awareness is essential.
- Good attention to detail and able to spot potential errors in own work and work of others.
- Highly literate and numerate with the ability to accurately record observations, facts, data and conclusions during experimental work or GMP investigations is essential.
- The ability to extract relevant information from scientific literature is essential.
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