The Senior Biological Scientist will participate in all activities of the Quality Control Laboratory in the Center of Excellence for Regenerative Health Biotechnology to provide qualitative and quantitative assessment of biopharmaceutical materials produced in or used by Florida Biologix. The incumbent will supervise assigned laboratory staff and ensure the completion of timely testing, laboratory upkeep and equipment related requirements. The incumbent will also independently develop, qualify, and conduct hands on cell-based, nucleic acid-based, protein-based, FACS -based and chemistry-based assays to support Manufacturing and Process Development including the development of appropriate in-house controls and selection of appropriate standards and their evaluation, as required. The incumbent will participate in assay technology transfer from clients and from Vector QC – PD, if appropriate. All work is performed according to written procedures and in compliance with cGMPs.
This position requires a criminal background check.
Learn and master technical and procedural assay steps for each assay quickly. Perform assays with accuracy and precision. Maintain accurate and precise records in compliance with cGMPs (laboratory notebooks, test records, inventory, etc). Flexibility, self-motivation, responsibility and dedication are necessary. Must supervise, perform and spend needed time to meet schedules and due dates. Position requires contact with human blood or other potentially infectious material ( OPIM ). This position requires the ability to work in a team environment to meet laboratory goals and timelines. Must treat subordinates and coworkers with respect and maintain team atmosphere to promote productivity and dedication. Must follow directions of Director, QC.
This position requires contact with human blood or other potentially infectious material ( OPIM ) and Human Pathogen Research (BSL2+/BSL3).
Daily, Monday through Friday, 8:00 AM to 5:00 PM. Evening, weekend and/or holiday work is required, dependent upon workload and to meet schedules 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.
A bachelor’s degree with five years of in-depth practical QC laboratory work experience, or a Master’s degree and 2 years of in-depth practical experience in the fields of biochemistry, immunology, molecular biology, cell biology and microbiology are desired for this position. Highly motivated, hard-working and multi-tasking person.
Technical understanding and hands on experience in the performance of a variety of QC biological assays, including cell-based (viability, tissue culture, FACS scan, TCID50, etc.), nucleic acid-based (restriction digests/gel electrophoresis, PCR , qPCR, spectrophotometric assays), protein-based ( BCA , SDS - PAGE , Western, ELISA , spectrophotometric assays), and chemistry-based assays (pH, Osmolality, etc).
Work experience in a cGMP QC testing environment. Hands on experience with assay qualification.
Supervisory experience in a laboratory environment of at least one year, a plus.
Must be able to speak, read, and write in English in order to interact with direct reports, write documents, analyze, compile, format and present data, technical information and written reports to internal staff and external clients/parties as necessary. Must have excellent organizational skills, be detail oriented and possess the ability to multi-task on a daily basis.
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).