A QC Scientist for Biopharm CMC, Biodistribution, has a demonstrated depth of expertise in molecular biology and the ability to support independent performance and troubleshooting of various DNA/RNA extraction techniques and various qPCR and RT-qPCR Responsibilities would include but not be limited to, analyzing and reviewing study data and methods, and drafting protocols and reports that meet GLP/GCP requirements. QC Scientists will be required to act as a Principal Investigator (PI) for GLP projects, or Responsible Scientist (RS) for GCP projects. The QC Scientist is required to have good working knowledge of the GLP/GCP and 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. 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, or be part of a larger cross-sectional project working in conjunction with a more experienced QC Scientist or Lead Scientist (LS). The role is accountable for the approval and integrity of data and associated quality documentation and provides scientific support and direction to laboratory operations.
In this role, the QC Scientist will provide internal customers with a central scientific point of contact for techniques within their area of expertise, or for external Clients where the QC Scientist is the scientific lead. The individual is accountable for effective communication directly with the Client to ensure that Client requirements and project deliverables are met. This includes discussion with the Project Management Office (PMO) and communication with managers 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.
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