Senior Microbiologist

Job Overview

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, you will lead all quality control related to antibiotic resistance testing and antimicrobial susceptibility testing in vitro diagnostic product manufacturing. Your responsibilities will include maintaining bacterial stocks, preparing and isolating antibiotic-resistant bacterial strains, and establishing processes for stock maintenance and bioburden testing. You will also create SOPs and processes for handling, plating, culturing, storing, and manipulating 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.

Responsibilities

• Maintain bacterial stocks and prepare and isolate antibiotic-resistant bacterial strains
• Establish processes for stock maintenance and bioburden testing
• Create SOPs and processes for handling, plating, culturing, storing, and manipulating BSL1 and BSL2 antibiotic-resistant bacterial strains
• Monitor and train laboratory staff in microbiological processes with strict adherence to quality standards and good laboratory practices
• Create, implement, and monitor processes for QC final release testing with bacterial strains for IVD products
• 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

Education and Skills

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. Alternatively, a Master's degree with 3-5 years of experience or a Bachelor's degree with 5+ years of experience in similar fields. 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. 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.