August Bioservices, LLC · 2 months ago
Microbiologist I/II (Weekend Shift)
Nashville, TN
Contract
Onsite
New Grad, Entry, Mid Level
0+ years expAugust Bioservices is a high-growth Contract Development Manufacturing Organization (CDMO) based in Nashville, TN, focused on drug discovery and manufacturing services. The QC Microbiologist I/II will support the microbiological control program in a sterile injectable manufacturing facility, ensuring compliance with regulatory requirements and maintaining aseptic conditions.
BiotechnologyMedicalPharmaceutical
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
Qualification
Required
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
Company
August Bioservices, LLC
August Bioservices, a leading sterile injectable CDMO headquartered in Nashville, Tennessee, delivers end-to-end contract development and manufacturing services for pharmaceutical and biotech clients.
51-200 employees
H1B Sponsorship
August Bioservices, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (11)
2023 (12)
2022 (2)
2021 (4)
Funding
Current Stage
Growth StageTotal Funding
$88.6MKey Investors
Oak HC/FTPolaris Partners
2022-12-01Series B· $65M
2021-05-27Series A· $23.6M
2020-07-16Series Unknown
Leadership Team
Mats Bjoerkman
Chief Financial Officer
Colette Lanzon
Talent Acquisition Business Partner
Recent News
Seattle TechFlash
2025-06-24
The Business Journals
2024-02-11
Company data provided by crunchbase