The Senior Biological Scientist will provide biologics process development support to ensure that the Center of Excellence for Regenerative Health Biotechnology ( CERHB ) Process Development Laboratory operates to provide clients with new production methods and investigational materials for pre-clinical use. The incumbent will design and conduct experiments to develop processes that will be implemented for cGMP production The incumbent will be responsible for the design of plasmids and bacmids constructs to generate different type of viral vector used for gene therapy. This position will also work in the bio-manufacturing facility and will work closely with Regulatory, Quality Assurance and Quality Control units. This position works collaboratively with clients and assists in transferring processes to the GMP manufacturing unit.
Production and isolation of recombinant proteins and viral gene transfer vectors; viral vector cloning, cell line and vector development; upstream process development. Transfection of biologically active DNAs in mammalian and insect cells, and transgene expression analysis. Technical transfer of processes and procedures from clients. Write process procedures (PDPRs, SOPs, production batch records, raw materials specifications, etc) and qualification protocols for new products. Search and source cGMP compatible equipment and raw materials. Assist the coordinator (manager) in the development and/or optimization and the implementation of processes for manufacturing methods.
Technically review of experiments/data for presentation. Participate in laboratory investigations, interpret data and work with the Coordinator to trouble-shoot technical problems. Participate in the optimization of methods, write and troubleshoot protocols. Execute process development experiments following process development protocols and/or production batch records. Assay development and assay standard validation. Project planning and time-line development. Prepare and modify documents (PDPRs, SOPs, Batch Records, Raw Material Specifications, etc). Laboratory maintenance and Production module preparation. Preventive maintenance of equipment.
Improve (make more time efficient, cost efficient, etc) existing GMP processes and procedures. Research and source assay reagents, equipment, and materials. Prepare assay cell banks; establish and validate assay standards.
Ensure that the Process development laboratory operates efficiently (reagent and raw materials sourcing and maintenance of inventory; experiment and equipment scheduling).
Monday through Friday 8am – 5pm, Requires availability to work in the evenings, holidays, weekends and overtime when required.
Must be able to maintain accurate records (laboratory notebooks, protocols, etc). Ability to gown aseptically to enter cleanroom. Ability to stand for long periods. Ability to lift up to 50 lbs. Occasional respirator usage is required. Flexibility, self-motivation, responsibility are highly desirable.
A bachelor’s degree in an appropriate area of specialization and three years 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 - 22 months ago