The Biological Scientist at the Center of Excellence for Regenerative Health Biotechnology’s Florida Biologix Process Development (PD) lab and cGMP manufacturing group will be responsible for assisting in the development of processes for the downstream purification/separation of vectors, viruses, small molecules, and proteins. The incumbent will work both independently and directly with the downstream manager in the execution of Process Development and cGMP purification protocols and processes, assist in writing and editing process development reports and production documents and perform related duties including buffer preparation, autoclaving, routine maintenance of equipment, ordering, etc.
Perform Process Development and cGMP compliant purification/separation processes and techniques as required by different projects. Participate in experiments to optimize and scale up purification steps in Process Development. Assist in transfer of developed processes to Manufacturing including all related tasks. Perform or assist in performing downstream purification processes under cGMP requirements and according to SOPs.
Perform other laboratory duties such as making buffers needed for above processes, preparation and autoclaving of required components, column preparation and all associated documentation. Perform these following procedures and in compliance with cGMPs.
Assist in drafting or revising required RMS’s, SOP’s, PDPRs, PBRs, reports, and deviations as they pertain to downstream/separation process development and manufacturing operations. Ensure acceptability to QA dept.
Assist in sourcing and ordering of raw materials, perform maintenance for both laboratories and equipment as required by procedures.
Other duties as assigned. Typically, Monday through Friday, 8:00 A.M. – 5:00 P.M.
Evening and weekend work is required to meet timelines and objectives, but on an intermittent basis.
A bachelor’s degree in an appropriate area of specialization and one year of appropriate experience. Appropriate college coursework may substitute at an equivalent rate for the required experience.
This is a time limited position.
University of Florida - 15 months ago