Microbiologist I/II (Weekend Shift)

August Bioservices•Nashville, TN

57d•Onsite

About The Position

Headquartered in Nashville, TN - one of the fastest-growing and most exciting cities in the United States - August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project - including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August! The QC Microbiologist I/II supports the microbiological control program in a sterile injectable (parenteral) manufacturing facility. This position plays a key role in maintaining the facility's aseptic control state by performing environmental and utility monitoring, microbiological testing of raw materials, in-process samples, and finished drug products. The role also includes data review, investigation support, and ensuring compliance with regulatory requirements and cGMP standards.

Requirements

Bachelor's degree in Microbiology, Biology, Biotechnology, or a related life science discipline.
Microbiologist I: 0-2 years of experience in a GMP-regulated microbiology laboratory within sterile drug manufacturing.
Microbiologist II: 2-4 years of experience supporting QC Microbiology operations for sterile injectables or other aseptically manufactured products.
Hands-on experience with environmental monitoring of cleanrooms and isolators as well as aseptic technique
Working knowledge of compendial methods (USP <61>, <62>, <71>, <85>, <1116>) and regulatory guidance (FDA, EMA, ICH Q7/Q9/Q10).
Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Strong attention to detail and commitment to data integrity.
Effective communication skills (written, verbal, and presentation).
Demonstrated initiative, accountability, and ability to work both independently and in cross-functional teams.
Flexibility to support off-shift or weekend sampling and testing based on manufacturing needs.
Ability to work in cleanroom gowning and controlled environments for extended periods.
Frequent standing, bending, and walking.
Ability to lift up to 25 lbs and handle routine laboratory equipment and sampling tools.

Responsibilities

Perform viable and non-viable environmental monitoring in ISO Class 5-8 cleanrooms, including aseptic filling areas (isolators and RABS).
Conduct personnel monitoring to assess aseptic technique compliance.
Collect and test utility samples (WFI, Purified Water, compressed gases) per approved sampling plans.
Trend and assess environmental and utility data to support cleanroom control and sterility assurance.
Perform microbiological assays including bioburden, endotoxin, and growth promotion testing.
Support and handle samples for media fills/aseptic process simulations.
Test raw materials, in-process, and finished products per USP, EP, and internal methods.
Maintain and verify microbial culture stocks, control strains, and reference organisms.
Document all work per cGMP and ALCOA+ principles.
Review, interpret, and ensure accuracy and traceability of analytical data.
Author, revise, and review SOPs, test methods, qualification protocols, and reports.
Summarize data trends and prepare monitoring review reports.
Provide microbiological input for environmental excursion and deviation investigations.
Support equipment and laboratory qualifications (e.g., autoclaves, incubators, isolators, particle counters).
Assist with method validations, verifications, and transfers.
Maintain a clean, compliant, and organized laboratory.
Follow biohazard and waste-handling procedures.
Participate in internal/external audits and provide technical support.
Identify and support laboratory process improvements and automation initiatives.