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 (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 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. Maintain appropriate in-house assay standards including inventory and database of each standard
’s performance in each assay. Other duties as assigned by supervisor.
Monday through Friday, 8:00 AM to 5:00 PM.
Evening, weekend and/or holiday work is required, dependent upon workload and deadlines.
This position requires the ability to work in a team environment to meet laboratory goals and timelines and as such requires appropriate behavioral characteristics to be effective and successful. Individual must be quick to learn technical and procedural steps related to each assay. Accuracy and precision is a must. Incumbent must be able to perform work in a timely manner and stay on schedule. Candidate must be willing to follow directions from the supervisor. Successful candidate must have the ability to read, write legibly, and follow written and verbal instructions in English.
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.