AntriaBio is a clinical stage biopharmaceutical company specializing in the development of innovative drug therapies to improve the lives of patients with diabetes and metabolic diseases. AntriaBio's lead product candidate is AB101, an injectable once-weekly basal insulin for Type 1 and Type 2 diabetes that addresses a $11 billion market where the current standard of care is a once-daily basal insulin injection.
Summary: The Microbiology Specialist will provide support and expertise to the microbiology program for a GMP pharmaceutical manufacturing facility, including the Environmental Monitoring (EM) Program and Aseptic Gowning Program, perform sampling and testing of clean utilities and process bioburden in support of the company’s Quality programs. The position requires a self-starter who can manage a diverse workload under tight timelines.
Responsibilities: With minimal supervision the Microbiology Specialist will:
- Coordinate, oversee and perform sampling and testing of in-house water systems
- Assist in scheduling of routine environmental monitoring of ISO 5, 7 & 8 cleanrooms and compressed dry air system. Duties include collection of EM samples and ownership of aseptic gowning program.
- Schedule routine cleaning of the GMP cleanroom facility and laboratories
- Review test results, perform data entry/verification, conduct investigations for OOS/OOT results and complete EM data trending
- Perform batch record and study protocol review from an environmental monitoring perspective
- Write and revise Standard Operating Procedures as needed
- Draft and execute microbiology study protocols for media challenges, method validation and other clinical-phase-appropriate studies (i.e., cleaning validation)
- Be the primary contact with sampling staff, contract laboratories and contract cleaners
- Coordinate work orders and scheduling of instrumentation calibration
- Perform multiple activities and manage multiple projects with limited direction
- Work cross functionally to achieve goals on tight timelines
- Maintain laboratory inventory, perform routine lab cleaning and send samples to contract labs
- Perform other tasks as required
Experience and Required Skills:
- BS or BA in Microbiology, Biology or Life Sciences with a minimum of five years pharmaceutical laboratory experience in a GMP environment.
- The position requires strong attention to detail, the ability to work in a team environment and focus on delivery of high quality results.
- The position requires experience with and an understanding of cleanroom practices, aseptic technique, aseptic gowning, Bacterial Endotoxin testing, Bioburden testing, Biological Indicator testing, and microorganism identification/ characterization
- Microsoft Office experience
- Knowledge of protein therapeutics a plus; Cleaning Validation experience a plus