Senior Microbiologist Researcher
hace 2 días
This role works closely with process development engineers to create quality control processes and transfer them into operations. As a subject matter expert for infectious disease IVD product development, the microbiologist leads all quality control related to antibiotic resistance testing and antimicrobial susceptibility testing in vitro diagnostic product manufacturing.
Responsibilities
• Maintain bacterial stocks by preparing and isolating antibiotic-resistant bacterial strains, establishing processes, and performing validations on procedures for stock maintenance.
• Perform incoming QC procedures of bacterial stocks on bacterial culture materials, prepare bacterial cultures for testing and long-term storage, and monitor bacterial stocks for antibiotic resistance.
• Create SOPs and processes for handling, plating, culturing, storing, and manipulation of BSL1 and BSL2 antibiotic-resistant bacterial strains, and monitor and train laboratory staff in microbiological processes with strict adherence to quality standards and good laboratory practices (GLP).
• Create, implement, and monitor processes for QC final release testing with bacterial strains for IVD products, and perform laboratory analysis on materials after appropriate sterilization.
• Develop various testing processes for raw materials and equipment, and monitor all finished products, analyze and interpret QC data from AST IVDs to monitor for trends or issues.
Requirements
• PhD in microbiology, medical or clinical microbiology, virology, clinical laboratory sciences, molecular biology, biochemistry, or similar background with at least 1-2 years of experience with microbiologic techniques.
• Proficient in standard biology laboratory techniques, such as laboratory math, micropipetting, pH, buffer preparation, etc.
• Experience with antibiotic resistance and/or antimicrobial susceptibility testing strongly preferred, and experience with bioanalytic and molecular biology techniques also preferred (ex. HPLC, mass spectroscopy, RT-PCR, NGS, ELISA etc.).
• Experience in a regulated environment or laboratory preferred (ex. ISO 13485, ISO 11737, ISO 11133, ISO 17325, ISO 15189, FDA, or similar).
• Excellent communication skills, ability to summarize and report results to upper management
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