Shift Analytical Chemist, ARD
Our Analytical Research and Development Department at Pfizer Research & Development in Sandwich UK plays a critical role in transforming patients' lives around the world by providing the analytical chemistry support for the development and manufacture of medicines for studies at all phases of clinical development. As part of Worldwide Research & Development in Pharmaceutical Sciences, we are responsible for the development and integration of analytical technology for the development and production of active pharmaceutical ingredients (API) and drug products.
To support the Research & Development portfolio using a broad range of separation, spectroscopy and detection techniques to deliver supplies of active pharmaceutical ingredient for use in clinical trials. To work closely with subject matter experts and project teams to provide timely quality data to chemists and production that facilitates the manufacture of materials and generation of data in support of regulatory documentation (e.g. new drug applications).
- Provides 16/5 support to the API manufacturing facility via a split shift system (rotating 1 week 6.45am to 2.55pm and 1 week 2.40pm to 10.50pm).
- Use a range of analytical techniques including liquid, gas and supercritical fluid chromatography, mass spectrometry, NMR and classical analytical techniques to provide support for in process control monitoring, testing of isolated product and cleaning verification.
- Excellent partnership with production, analytical and chemistry project teams and quality assurance is essential.
- The role requires significant autonomy to achieve consistently high-quality results within agreed timeframes. Critical attention to detail, strong organisational skills, the ability to multitask and confident raising questions when faced with uncertainty .
- Independently carry out all aspects of practical work necessary to provide right first time results to allow batch progression and build product understanding.
- Assisting in the maintenance and renewal of laboratory instruments, systems or apparatus and in the maintenance and continuous improvement of safe and effective working practices.
- Maintaining written records of all experimental work in accordance with current Good Manufacturing Practice, data integrity principles and according to standard operating procedures.
- Maintaining a contemporary awareness of Pfizer Business Practices, methods, specifications, SOPs, Pharmacopeial trends, ICH Guidelines and regulatory expectations.
- Direct supervision is not an envisaged part of the role, but it is expected that the successful candidate will show supportive leader behaviours and be a positive advocate for new technology, process improvements and initiatives designed to increase efficiency, digital work practices, quality and compliance.
Qualifications, Experience and Skills
A minimum of a Bachelor's degree in chemistry, Analytical Chemistry, Pharmaceutical Sciences or a related discipline, or have equivalent directly related experience.
- Practical experience with running, transferring and troubleshooting techniques relevant to QC testing; uHPLC, HPLC, GC, SFC, FT-IR, Raman etc. with a good understanding of the key specification and characterisation tests as applied to API release and stability e.g. assay, process related impurities and degradation products, solid form, particle size, etc.
- Excellent lab safety awareness.
- Highly literate and numerate with the ability to accurately record observations, facts, data and conclusions during experimental work or GMP investigations.
- Able to critically evaluate work / results to spot potential errors in own work and the work of others, attention to detail is a key skill.
- Comfortable working as part of diverse multi-disciplinary, cross-functional, global teams.
- A strong desire to develop own technical skill set and knowledge of cGMP regulations.
- The abilityto extract relevant information from scientific literature and Pharmacopeia.
- Resilient and self-aware, a team player who manages change and ambiguous situations successfully.