The Senior Biological Scientist will independently develop, qualify and conduct cell-based, nucleic acid-based, protein-based, and chemistry-based assays to support process development and quality control of biopharmaceutical products being developed and manufactured at Florida Biologix under contract. These assays are for the qualitative and quantitative assessment of biopharmaceutical materials produced in or used by Florida Biologix, a contract biopharmaceutical manufacturing facility operated by the Center for Regenerative Health Biotechnology.
The incumbent will independently develop, qualify and then perform and evaluate the results of qPCR assays, gel electrophoresis assays, Western blot assays, quantitative protein assays (i.e., Bradford, Lowry, BCA , etc.), ELISAs, spectrophotometric assays, cell viability assays, infectivity assays and other assays related to the safety and release testing of intermediate and final biological products (toxicological and clinical materials), and their stability, manufactured by Florida Biologix. These assays must be performed according to written procedures and in compliance with cGMP regulations. Assist in planning and performing experiments leading to the qualification of release tests. These projects require independent literature research to determine appropriate techniques. Write test records, reagent preparation records, and other controlled documents. Perform experimental assays to establish and qualify theses assays and to assist in troubleshooting. Maintain complete and accurate records of all work performed. Maintain equipment records as required by procedure. Write planned variances, deviation reports, track stability data, etc. in compliance with cGMPs. Order laboratory supplies and maintain required inventory according to standard operating procedures.
Maintain sample inventory system including daily database entries. Participate in laboratory upkeep and required equipment calibration and preventive maintenance. Maintain appropriate in-house assay standards including inventory and database of each standard
’s performance in each assay.
Daily, Monday through Friday, 8:00 AM to 5:00 PM. Evening, weekend and/or holiday work is mandatory, dependent upon workload and deadlines.
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.
A Master’s degree and three years of in-depth laboratory work experience in the fields of biotechnology, immunology, molecular biology, cell biology, or virology are desired for this position. Hands on experience in the performance of a variety of biological assays, including cell-based (viability, tissue culture, infectious titer), nucleic acid-based (restriction digests/gel electrophoresis, PCR , qPCR, DNA sequence analysis, spectrophotometric assays), protein-based ( BCA , SDS - PAGE , Western, ELISA , spectrophotometric assays), and chemistry-based assays (pH, Osmolality, etc); including technical understanding of assay principles. Candidate with hands-on experience with assay development and assay qualification in a cGMP compliant Quality Control laboratory will be given preference. Work experience in a cGMP testing environment is highly desired. Candidate must have excellent organizational, oral, and written communication skills including MS based programs including Word, Excel, Access and Outlook.
Health Assessment Required:
Special instructions to applicants:
Post offer health assessment is required for contact with human blood or other potentially infectious material ( OPIM ) and Human Pathogen Research (BSL2+/BSL3).
University of Florida - 7 months ago