Microbiologist

Job Description

About Civica:

In the last 20 years, the U.S. has faced a significant rise in shortages of essential generic injectable medications, with over 300 reported shortages. This crisis stems from “race to the bottom” pricing, manufacturing challenges, and predatory pricing, ultimately impacting patients the most.

Civica, a 501(c)(4) social welfare organization founded in 2018 by various health systems and philanthropies, aims to combat these shortages and high prices. With over 55 health systems representing 1,500 hospitals, Civica also supplies essential medicines to the U.S. Department of Veterans Affairs and the Department of Defense. Their guiding principle is to “Do What Is in the Best Interest of Patients.”

Recently, Civica has expanded its mission to include affordable biosimilar insulin, ensuring consistent availability for those in need. Learn more at www.civicarx.org.

Job Description

The Microbiologist will support Civica’s Petersburg, Virginia site, focusing on establishing and maintaining the microbiology testing laboratory and environmental monitoring. This role ensures compliance with regulatory standards and involves generating and reviewing necessary documentation.

Essential Duties and Responsibilities:

• Establish and maintain the microbiological testing laboratory in compliance with cGMPs.
• Perform microbiological testing per USP requirements, including bioburden and endotoxin testing.
• Conduct equipment qualifications and maintenance.
• Coordinate test sampling plans and perform environmental monitoring.
• Participate in method verification and training program development.
• Lead investigations related to lab operations and non-conforming results.
• Conduct quality risk assessments and promote a quality mindset.
• Travel may be required.

Basic Qualifications:

• Bachelor’s degree in a scientific discipline (microbiology preferred) with 4+ years of cGMP experience.
• Strong project management and organizational skills.
• Experience in microbiology testing and environmental monitoring.
• Excellent communication skills and proficiency in software applications.
• Self-motivated and adaptable in a fast-paced environment.
• Committed to high-quality results and continuous learning.

Preferred Qualifications:

• Experience in sterile injectable manufacturing and aseptic processing.
• Familiarity with sterility testing and biological indicators.