Job description
- Provides 16/5 support to the API manufacturing facility via a split shift system; rotating weeks of early shifts (6.45am to 2.55pm) and late shifts (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.
- Bachelor's Degree
- Demonstrable experience
- Experience with interdisciplinary drug development teams and industrial experience developing analytical strategies and methods in support of product and process development and to assess the quality and characteristics of biotherapeutics
- Experience working in a regulated environment, such as Good Laboratory Practices {part of GxP}
- Demonstrated technical expertise in functional verification of design
- Working knowledge of applicable industry test standards, relevant regulatory guidance, Design Controls and Product Development Process
- Able to interact effectively with peers and leaders as part of a multi-disciplinary team
- Effective verbal and written communication skills
- Relevant work experience in a pharmaceutical laboratory role supporting API, intermediates, or drug product.
- Experience in supporting shift operations and working to a shift pattern
- Hands on knowledge of informatic systems including laboratory data acquisition, electronic notebooks, documentation, material deposition, quality incident management.
- Experience in supporting or handling GMP quality and compliance issues resulting from GMP deviations, process issues, material, and product defects.
- Knowledge of the principles of method development and validation requirements as applied to spectroscopic and chromatographic techniques.
Work Location Assignment: On Premise