Microbiology Lab Scientist (Med Tech)

Thermo Fisher Scientific

Highland Heights, KY

Shift: Full time

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting Job Description This is a fully onsite role based at our Global Central Laboratory in Highland Heights, KY . We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. 1st shift: Monday - Friday with rotating weekend At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. Microbiology Laboratory Scientist – Job Description Overview Responsible for analyzing biological samples to detect, identify, and study microorganisms (bacteria and parasites). Trains on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines. Performs routine sample preparation and analysis procedures. Transitions to more complex techniques/procedures and performs analysis throughout role tenure. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol, and product specifications. Key Responsibilities/Essential Functions Perform microbiological testing on clinical trial patient samples (stool, urine, sputum) Culture and isolate microorganisms using appropriate media and techniques Identify organisms using biochemical tests, microscopy, molecular methods or automated systems Conduct antimicrobial susceptibility testing (AST) Maintain accurate lab records and document results in LIMS systems Ensure compliance with laboratory safety and quality standards (CLIA, CAP, GLP) Calibrate, maintain, and troubleshoot laboratory instruments Interpret and report test results to physicians, researchers, or stakeholders Participate in method development, validation, and quality control procedures Follow biosafety protocols and infection control procedures Trains on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines. Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs. Reviews and compiles results from assignments and makes initial determination on acceptability per SOP acceptance criteria. Problem solves with assistance pertaining to extraction and/or instrumentation problems. Performs work assignments accurately, and in a timely and safe manner. Manages QC responsibilities with minimal/no supervisor input. Communicates project status to project leader. Builds an understanding of QA processes and manages responsibilities with decreasing supervisor or QA input Required Skills & Competencies/Job Knowledge Strong understanding of microbiology principles (bacteriology and parasitology) Hands-on experience with: Aseptic technique Culture methods Microscopy Molecular/Immunological diagnostics Knowledge of laboratory regulations and documentation practices Attention to detail and strong analytical skills Ability to work independently and in a team Problem-solving and troubleshooting ability Familiarity with lab software/LIMS systems Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines. Knowledge of applicable regulatory authority, compendia and ICH guidelines Demonstrates excellent manual dexterity skills, allowing for precise and accurate work. Exhibits strong written and oral communication skills, facilitating effective communication within the team and with stakeholders. Displays exceptional time management and project management skills, ensuring efficient completion of