The CE Stream of BioPharmCMC is a fast paced, dynamic regulatory environment. Analysts within this department perform a range of techniques including Compendial methods, UV, SDS-PAGE, Capillary Electrophoresis and Isoelectric Focussing in order to support market release, batch release and stability testing on behalf of our Clients. In addition to the lab based activities analysts also have the opportunity to expand their skill set via study supervision responsibilities, lab operations support and involvement with process improvement projects.
The individual has a responsibility to work with QC Scientists (QC SCi) to conduct all work in compliance with applicable regulatory requirements, and specifically those regulations (GLP and or GCP / and or GMP) specified in the study plans, protocols, or work agreements governing the work in which they are involved, and ensuring that client deadlines are met. They are also responsible for the efficient completion of analytical procedures within BioCMC.
To provide operational support necessary for the performance of a wide variety of studies carried out in BioPharmCMC. Will participate in a wide range of analytical techniques & procedures and working with minimal supervision is required. Will work closely with QC SCi to ensure procedures/studies are performed according to scientific and technical standards.
It may occasionally be necessary for the post holder to provide appropriate procedural and technical training for BioPharmCMC staff.
Reports to the Experimental Officer III on a daily basis (a permanent change of supervisor will be documented in training records) and to the relevant QC SCi on a study specific basis.
The post holder will ensure adherence to the BioPharmCMC SOPs and will be responsible for completion of all relevant documentation.
The post holder should ideally have a relevant scientific degree and/or an appropriate amount of laboratory experience.
The post holder should typically have: