Manage laboratory setup, training, production, labeling, and distribution of blood component production at blood center partner sites in support of clinical research objectives, while minimizing product wastage.
Manage and support laboratory setup and training at manufacturing sites and hospital partners.
Manage all aspects of blood component production and distribution operations for clinical study and research manufacturing sites.
Perform Lean process flow analysis and provide recommendations for improvement.
Ensure minimal product wastage.
Manage, develop, and maintain order fulfillment and distribution processes from clinical blood center production sites to participating hospitals.
Collaborate with blood center production and hospital sites to ensure patient needs are met for each clinical study or product development activity.
Develop and implement production forecasting and planning tools to ensure blood component availability, ensuring opportunity for study subject enrollment at various sites.
Monitor inventory on a regular basis to ensure appropriate ‘par levels’ are maintained by blood component type, and blood group type at blood center production sites and hospital partners.
Monitor all sites for adherence to quality and regulatory standards.
Dashboard metrics for managing the performance of clinical study manufacturing sites.
Participate in and/or host internal and external cross functional meetings relating to blood component production.
Strategically partner with internal and external stakeholders to effectively communicate, manage and mitigate any risks related to the supply chain for clinical trials.
Willingness to travel 75% + of time.
Valid unrestricted driver’s license.
Perform other duties as assigned.
Skills and Experience
Demonstrated leadership with a minimum of 1 – 5 years of experience in blood component production planning and inventory management.
Strong understanding of blood component receipt, production, labeling, and distribution processes.
Proven problem solving, communication and interpersonal skills.
Clear and concise ability to communicate and collaborate with key stakeholders on all levels.
Must be able to work in a fast paced environment with demonstrated ability to effectively manage multiple competing tasks and demands.
Good organizational skills, self-directed, and attentive to detail.
Strong user of Microsoft Office Suite, with emphasis on Excel, PowerPoint and Visio
Data analysis skills and lean (six sigma style) background.
Bachelor’s degree in relevant field (or greater than 5 years of blood banking experience).
MT or MLS preferred but not required.
cGMP and or cGLP expertise preferred.
About Cerus Corporation
Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT system is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action enables INTERCEPT treatment to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, and is designed to inactivate emerging pathogens such as influenza, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in the United States, Europe, Russia, the Middle East and selected countries in other regions around the world. The INTERCEPT red blood cell system is in clinical development.