The Biological Scientist will perform cGMP manufacturing to ensure that Florida Biologix at the Center of Excellence for Regenerative Health Biotechnology ( CERHB ) provides clients with new investigational materials for clinical use. The incumbent will lead cGMP production campaigns under the supervision of the Research Coordinator (Upstream PD Manager) and maintain production suites in the cGMP facility. Responsibilities include researching and sourcing reagents, equipment, and materials for specific production campaigns; preparing cell and viral vector banks; producing and isolating recombinant proteins and viral gene transfer vectors. Functions will also involve transfection of mammalian cells. The incumbent is expected to prepare and modify production documents (SOPs, PBRs, RMSs, etc). The selected candidate will be responsible for the maintenance of equipment in the upstream production suites as well as ordering equipment and overseeing their installation and qualification. This incumbent will be responsible for proper material staging of production suites in the cGMP facility. This position will also work closely with Facilities, Quality Assurance, and Quality Control units.
This position will also support process development activities when required and assist with routine PD lab assays including qPCR and cell based assays. The incumbent will also conduct experiments and analyze data for presentation; participate in laboratory investigations, work with the Coordinator to trouble-shoot technical problems; and organize experiment and production results for reports. The incumbent will participate in the optimization of methods and the writing and troubleshooting of protocols. Prepare and maintain cGMP production suites and perform manufacturing according to production batch records. Perform calibration, preventative maintenance of equipment at interval specified by SOPs. Write and revise process procedures (SOPs, PBRs, RMS and other controlled documents) and qualification protocols for new products and equipment. Search and source cGMP compatible equipment and raw materials. Assist in the execution and the review of IQ, OQ and PQ equipment protocols. Improve (make more time and cost efficient, etc) existing cGMP processes and procedures. 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 Generate data, analyze and evaluate. Other duties as assigned.
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 production schedules and timelines.
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.
Bachelor’s and three years of work experience in the fields of virology, molecular biology, biochemistry, and/or cell biology.
Hands on experience in cell culture (small and large scale), transfection, infection, gene transfer vector 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.
Practical experience with upstream processes and familiarity with downstream processing methods.
Experience in a cGMP production and testing environment.
Excellent communication skills including technical writing.
Ability to gown aseptically to enter cleanroom. Ability to stand for long periods and wear respirator. Ability to lift up to 50 lbs. Ability to maintain accurate records. Flexibility, self-motivation, efficiency and responsibility are required for this position.
Health Assessment Required:
Special instructions to applicants:
Post offer health assessment is required for heavy lifting up to 50 lbs and occasional respirator usage.