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 purification methods and investigational materials for pre-clinical use. The incumbent will design and conduct experiments under the supervision of the Scientific Research Manager. This will involve researching and sourcing reagents, equipment, and materials; preparing columns; purifying recombinant proteins, viral gene transfer vectors and smal molecules utilizing working knowledge in filtration technologies, column chromatography ( SEC , affinity, HIC , and ion exchange) and downstream process development. This position will also be expected to technically review data, prepare experiments/data for presentation, participate in laboratory investigations, interpret data and work with the Scientific Research Manager to trouble-shoot technical problems, and organize the results for reports. The incumbent will participate in the optimization of purification methods and the writing and troubleshooting of protocols. This position will assist in project planning and time-line development. The incumbent is expected to prepare and modify documents (PDPRs, SOPs, Batch Records, Raw Material Specifications, etc) and assist in maintaining the process development laboratory, including: participating in the maintenance of equipment and the laboratory, and ordering equipment and reagents. This position will also work closely with the Manufacturing, Quality Assurance and Quality Control units. This position works collaboratively with clients and assists in transferring processes to the GMP manufacturing unit. 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 Scientific Research Manager in the development and/or optimization and the implementation of processes for manufacturing methods. Execute process development experiments following process development protocols and/or production batch records. Generate data, analyze and evaluate. Production module preparation. Preventive maintenance of equipment. Improve (make more time efficient, cost efficient, etc) existing purification processes and procedures. Prepare and revise existing documents and records. Ensure that the Process development laboratory operates efficiently (reagent and raw materials
sourcing and maintenance of inventory; experiment and equipment scheduling). Other duties as assigned. Friday 8am – 5pm, Requires availability to work in the evenings, holidays, weekends and overtime when required.
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 - 21 months ago