Working as part of the QC Laboratory Operations Group, the QC Scientist routinely manages a number of assays pertaining to cell based assays. Typically, the QC Scientist will be responsible for single projects (for one or several related techniques), may be part of a larger cross-sectional team leading small to medium multi-technique projects (as a molecule lead), or be part of a larger cross-sectional project working in conjunction with a more experienced QC Scientist or Lead Scientist (LS).
The QC Scientist will serve as scientific point of contact for internal or external customers for techniques related to cell based assays. Project requirements may include, but are not limited to; assay transfer, validation, sample analysis, batch/release testing, and stability studies. They will write protocols and reports, prepare and review analytical procedures, and be accountable for the approval and integrity of data and associated quality documentation. The QC Scientist has in-depth knowledge about cell based assays and is able to troubleshoot techniques in these areas.
The QC Scientist is accountable for effective communication either directly with the Client or via the molecule lead, to ensure that Client requirements and project deliverables are met. This includes discussion with the Project Management Office (PMO), molecule lead if applicable, and communication with Team Leader and or Manager, as well as other scientific and analytical staff. The QC Scientist has scientific oversight of relevant techniques in order to ensure the successful initiation, planning, execution, monitoring and completion of projects.
The QC Scientist is required to have knowledge of regulatory guidelines as they ensure that projects are carried out to the required standards and that work is conducted in compliance with applicable regulatory requirements.
The QC Scientist may be required to perform lab work and will provide support to general laboratory operations and processes, leading by example to members of the QC operations team.
The post holder will adhere to the BiopharmCMC SOPs and will be responsible for completion of all relevant documentation.
The position may be associated with line management responsibilities. Additionally, project specific supervision will be required as appropriate.Education/Qualifications: