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) and Contract Research Organization (CRO). 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!
August Bioservices is looking for a Quality Control team member that is passionate and driven professionally. August Bioservices desires a team member eager to work in an environment where people are motivated to do their best for the company and its clients.
Reporting to the Manager, Microbiology, the Microbiologist I will be responsible for performing biological assays of raw materials, in-process samples, finished product, and environmental monitoring samples. He/she will work with microbiology personnel to assure test results, procedures, and methods are written, maintained, executed, and approved in accordance with approved SOPs and regulatory requirements.
- Perform environmental monitoring in ISO Class 5,6,7&8environments
- Support microbiology laboratory operations
- Investigate and troubleshoot equipment, testing and process abnormalities
- Perform biological assays of raw materials, in-process samples, and drug product
- Prepare and present data summaries
- Accurately document all necessary and relevant information in a clear and concise manner per cGMPs
- Author, revise, and review standard operating procedures, test methods, work instructions, and protocols
- Maintain clean, orderly, and safe laboratory work area
- Assist in the development of microbiological laboratory testing procedures
- B.A./ B.S in Biology (or related) and 0-2 years of pharmaceutical experience
- The ability to work flexible hours on short notice due to manufacturing demand
- Ability to work with minimal supervision
- Work in a team environment with well-developed interpersonal skills and excellent organizational skills
- Self-starter and ability to work independently
- Strong written/verbal communication and presentation skills
- Working knowledge of microbial enumeration testing, environmental monitoring of ISO classified environments, and bacterial endotoxin testing
- Working knowledge of cGMP, FDA, ICH, USP, and other regional and country specific guidance
- Proficient in Microsoft Word, Excel, Outlook, and PowerPoint
At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule - from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.
We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!
August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.