Microbiology Production Specialist

Role Overview

We are seeking a highly organized and detail-oriented Microbiology Production Specialist to join our team at the Nicholasville, KY manufacturing facility. The successful candidate will be responsible for executing microbiological manufacturing processes, including bacterial, viral, and fungal culture preparation, as well as maintaining biobank inventory. This role requires compliance with Good Manufacturing Practices (GMP) and ISO 13485:2016 standards, hands-on experience with microbiological techniques, aseptic workflows, biobank management, strong documentation skills, and the ability to work both independently and collaboratively in a fast-paced production environment.

This is an onsite position. No remote or hybrid work allowed.

Key Responsibilities

Manufacturing, Biobank Management & Laboratory Operations:

• Prepare and manufacture custom microbiology-based products, including bacterial, viral, and fungal cultures, following established protocols and quality standards.
• Perform aseptic culturing, propagation, and maintenance of bacterial, viral, and fungal strains while ensuring contamination control.
• Operate and maintain laboratory equipment, including biosafety cabinets, incubators, centrifuges, spectrophotometers, and automated liquid handling systems.
• Conduct microbiological assays, including microbial enumeration, viability testing, and contamination screening to ensure product quality.
• Package and organize microbiological products for shipping, ensuring accurate labeling, documentation, and compliance with regulatory standards.
• Maintain accurate and thorough documentation of all production and biobank activities using provided templates and software applications.
• Manage and maintain a comprehensive biobank of bacterial, viral, and fungal strains, ensuring proper cataloging, traceability, and storage under appropriate conditions, including ultra-low temperature, cryogenic, and standard refrigeration storage.
• Conduct routine viability assessments, quality control checks, and replenishment of biobank materials to ensure sample integrity and availability.
• Track biobank inventory using database systems, ensuring accurate record-keeping and compliance with regulatory and quality standards.
• Update, draft, and revise standard operating procedures (SOPs) and work instructions as required.
• Assist with troubleshooting deviations, optimizing workflows, and ensuring consistent product quality through continuous process improvement.

Required Qualifications:

• Bachelor’s degree in Microbiology, Virology, Mycology, Biochemistry, or a related field.
• Hands-on experience with microbiological techniques in a production or laboratory environment.
• Proficiency in operating laboratory instruments and aseptic handling of microbial cultures.
• Strong organizational skills with meticulous attention to detail and accurate record-keeping.
• Ability to troubleshoot and resolve issues independently while adhering to protocols.
• Self-motivated, proactive, and capable of working with minimal supervision.
• Strong commitment to quality, safety, and regulatory compliance.

Preferred Qualifications:

• Familiarity with ISO 13485:2016 standards or equivalent regulatory frameworks.
• Previous experience with biobanking of isolates and patient samples.
• Experience working with viral inactivation processes and fungal identification techniques.
• Experience working in an ISO-certified environment with strict contamination control measures.
• Knowledge of lean manufacturing principles and quality management systems.
• Previous experience in a GMP-compliant microbiological production environment.