Responsible for compliance and staff education of all nhdldcc and nhpcc studies including quality assurance programs. This position is responsible for the preparation of all audits. Also included is the assuring of compliance with all fda regulations, ich guidelines and irb policies.
The Research Technician will use their analytical capabilities to solve business problems, manage the R&D program portfolio, track performance metrics, identify business opportunities, and address R&D needs as they arise
The chosen candidate will be responsible for process development, scale-up, technology transfer, establishing and optimizing commercial manufacturing processes for compounding and filling of solids, soft-chews, non-sterile liquids and sterile inject (aseptic manufacturing) platforms, as well as collaborating and partnering with Manufacturing, Engineering, and Quality organizations.
In this role, you will be responsible for creating predictive models, testing and deploying tools. Working knowledge and familiarity with statistical models and scalable data mining techniques are essential.
The scientist is responsible for assisting with ensuring appropriate and timely analytical testing in support of manufacturing, regulatory compliance, and Research and Development. They must possess good time management skills in order to meet aggressive deadlines.
Act as a lead engineer on a project by providing technical leadership and management to projects. Such responsibilities may include project scheduling, allocation of design resources, coordination of design engineer activities, providing supervisory guidance to team members, and monitoring and controlling technical activities for design projects.
In this role, the selected candidate will be responsible for the cold call as appropriate within your market or geographic area to ensure a robust pipeline of opportunities; meet potential clients by growing, maintaining, and leveraging your network.
In this role, the selected candidate will assist with the coordination of clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted by the Levine Cancer Institute, following industry standards and applicable regulations including FDA/OHRP guidances, GCP and ICH.
In this role, you will be to conduct a tobacco variety development program utilizing available breeding technologies and innovations while developing a complete knowledge of tobacco germplasm and commercial products.