The Senior Biological Scientist will support process development and cGMP manufacturing activities to ensure that Florida Biologix at the Center of Excellence for Regenerative Health Biotechnology ( CERHB ) provides clients with new production methods and investigational materials for pre-clinical use. The incumbent will design and conduct experiments under the supervision of the Research Coordinator (Upstream PD Manager) as well as researching and sourcing reagents, equipment, and materials; preparing cell and viral vector banks; producing and isolating recombinant proteins and viral gene transfer vectors. Functions will also involve transfection of biologically active DNAs into mammalian cells followed by transgene expression analysis. This incumbent will also be expected to perform various assays when needed; to technically review data produced by self and others; to prepare experiments/data for presentation; to participate in laboratory investigations, interpret data; to work with the Coordinator to trouble-shoot technical problems; and to organize experiment and production results for reports. The incumbent will participate in the optimization of 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, PBRs, RMSs, etc) and assist in maintaining the process development laboratory and production suites in the cGMP facility. The selected candidate will be responsible for the maintenance of equipment in the laboratory and in the upstream production suites as well as ordering equipment and overseeing their installation and qualification. This incumbent will be responsible for proper staging and executing production runs in the cGMP facility. This position will also work closely with Facilities, Quality Assurance, and Quality Control units. This position works collaboratively with clients and assists in transferring processes to the cGMP manufacturing. Technical transfer of processes and procedures from clients. Write process procedures (PDPRs, SOPs, PBRs, RMS and other controlled documents) and qualification protocols for new products. Search and source cGMP compatible equipment and raw materials. Assist in the execution and the review of IQ, OQ and PQ equipment protocols. Assist the Research Coordinator (Upstream PD manager) in the development and/or optimization and the implementation of processes for manufacturing.
Execute process development experiments following process development protocols and performed cGMP manufacturing activities. Generate data, analyze and evaluate. Prepare production suite and execute production batch records. Perform calibration, preventative maintenance of equipment at interval specified by SOPs. Improve (make more time and cost efficient, etc) existing cGMP processes and procedures. Perform assays. Prepare and revise existing documents and records.
Ensure that the Process development laboratory operates efficiently (reagent and raw materials sourcing; and maintenance of inventory; and experiment scheduling). Other duties as assigned.
Ability to gown aseptically to enter cleanroom. Ability to stand for long periods and wear respirator. Ability to lift up to 25 lbs. Ability to maintain accurate records. Flexibility, self-motivation, efficiency and responsibility are required for this position.
Typically, Monday through Friday, 8:00 A.M. – 5:00 P.M. Requires availability to work early in the morning, in the evenings, holidays, weekends and overtime when required to meet timelines.
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.
’s and three years of work experience in the fields of virology, molecular biology, biochemistry, and/or cell biology.
A bachelor’s degree in an appropriate area of specialization (molecular biology, virology, biochemistry, immunology) and three years of appropriate experience in same or related fields.
Hands on experience in cell culture (small and large scale), transfection, infection, rAAV production by transfection and by using baculovirus systems.
Working knowledge of modern laboratory procedures and biology techniques.
Familiarity with gene therapy vectors and knowledge of local, state and national regulations for working at the P1 and P2-levels of biological contaminant.
An in-depth understanding of upstream and good knowledge of downstream processing methods.
Experience in a cGMP production and testing environment. Excellent communication skills including technical writing.
Health Assessment Required:
Special instructions to applicants:
Post offer health assessment is required for occasional respirator use and heavy lifting up to 25 lbs.
University of Florida - 12 months ago