Streck is recruiting for a Microbiologist within our newly created Clinical Affairs area. This position will be responsible for designing and writing the requisite protocols/procedures and executes required microbiology assignments, including sourcing all applicable antimicrobial resistance targets and prepares sample requirements as specified in the FDA pre-submission. Where applicable, formats data into an analyzable arrangement and reports findings accordingly. Executes quality assurance practices, including equipment maintenance, method validations and standard operating practices and procedures, specific to both microbiology and molecular biology test methods.
The primary responsibilities include:
- Responsible for microbiology-based applications, including culture growth, organism identification, maintenance, stocking, spike-in studies, plating and antimicrobial resistance testing. Additionally, experience with molecular genetic tests, including DNA/RNA extraction, real-time PCR, Sanger and next-generation sequencing.
- Design, develop and execute experimental protocols and write reports, specific to the culturing of biosafety level 2 microorganisms, spiked into negative biological matrices and grown for characterization of antimicrobial resistance patterns as measured by real-time PCR and next-generation sequencing.
- Plan and manage delivery of microbiology specimens in accordance with the experimental objective. Identify required resources for budgetary purposes and characterize deliverables and communicate schedule for delivery/availability. Escalate as necessary when circumstances external to the project threaten the planned timeline.
- PhD degree in Microbiology preferred. Relevant laboratory experience and performance may be substituted for an upper level degree or years of experience.
- Experience in Antimicrobial Susceptibility Testing (AST) and United States Pharmacopeia (USP) methods, including Minimal Inhibitory Concentration (MIC), Minimal Bactericidal Concentration (MBC), Time Kill Kinetics, Post-Antibiotic Effect and Resistance Profiling (molecular and phenotypic).
- Prior project management experience.