The Biological Scientist participates in the day to day operation of cGMP compliant Quality Control laboratories of the Center of Excellence for Regenerative Health Biotechnology (Florida Biologix) in Alachua, FL. Responsibilities include performing laboratory analytical and biological procedures in compliance with current Good Manufacturing Practices for the qualitative and quantitative assessment of biological drug substances, raw materials, final biological drug products, cell banks, viral banks, in-process samples, and process development samples.
Assist in development of new assays and perform assay qualification.
Perform of FACS analysis, ViCell viability and cell counting, cell culture assays and other QC methods for testing of biological substances including preparation of any needed reagents, buffers, etc. This work must be performed in accordance with Standard Operating Procedures and Test Records, with a high level of accuracy and consistency. Analyze assay results, complete accurate records, prepare tables, write reports, scan gels or prepare graphs; meeting all schedules and deadlines.
Conduct agarose and polyacrylamide gel electrophoresis and subsequent staining protocols, Western blots, ELISAs, and PCR assays in accordance with Standard Operating Procedures and Test Records, with a high level of accuracy and consistency. Analyze assay results, complete accurate records, prepare tables, write reports, scan gels or prepare graphs; meeting all schedules and deadlines.
Assist the Manager in new assay development activities including research new methods, develop new assays, draft qualification protocols, conduct qualification experiments, assemble data and draft reports. Write draft test records, reagent preparation records, raw material specifications as assigned.
Order all necessary supplies, chemicals, plastic ware, etc. needed for assay performance.
Perform laboratory and equipment cleaning, preventive maintenance and calibration as described in written procedures. Maintain appropriate in-house databases for samples and in house controls inventories.
Other duties as assigned.
Work schedule will vary from week to week. Schedule will be set on a monthly or weekly basis, requiring night, weekend and holiday hours. Must be flexible to meet production requirements.
Work requires contact with human blood or other potentially infectious material ( OPIM ) and Human Pathogen Research (BSL2+/BSL3).
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.