About Civica:

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at www.civicarx.org

Job Description

The Microbiologist II will join the Civica organization at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica’s new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. Responsibilities of the position include supporting the establishment and maintenance of the microbiology testing laboratory and facility environmental monitoring sampling.

The role is essential to ensure the Petersburg site’s microbiology laboratory and testing comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices and FDA Guidance documents) and expectations for the development and reliable supply of quality medicines. Responsibilities also include, but are not limited to, manage laboratory studies, generation and/or review of procedures, reports, and other records necessary to support the design, implementation, and maintenance of a microbiology laboratory that meets or exceeds FDA requirements.

Essential Duties and Responsibilities:

• Support the establishment and maintenance of the microbiological testing laboratory to ensure compliance with cGMPs and industry standards for best practices.
• Perform microbiological testing methods consistent with USP testing requirements. Including but not limited to the following microbiological testing and procedures: bioburden, bacterial endotoxin, identification of microbial isolates and objectional organisms, viable/non-viable particulate monitoring, and growth promotion studies.
• Conduct and maintain qualifications of laboratory equipment as well as ongoing maintenance and calibration.
• Establish and coordinate test sampling plans.
• Perform microbiological testing and sample collection to support environmental monitoring (EM) and utilities systems.
• Participate in the verification of microbiological methods and method transfers.
• Provides guidance to team members related to microbiology and sterility assurance.
• Participate in the development of training programs for microbiologist.
• Lead and/or participate in investigations related to laboratory operations and non-conforming results.
• Applies functional and technical expertise to Identify, solve, track, and facilitate resolution of technical issues.
• Conduct quality risk assessments related to microbiology and environmental monitoring.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Author and/or review SOPs, protocols, reports, test method and product specification documents as applicable.
• Promote a quality mindset and quality excellence approach to all activities.
• Travel may be required.

Basic Qualifications and Capabilities:

• Bachelor’s degree in a scientific discipline (microbiology degree preferred) with a minimum of 6 years Quality/cGMP experience in the pharmaceutical industry.
• Strong project management, organization, and execution skills.
• Microbiology testing and environmental monitoring experience.
• Experience with European Union Standards is required.
• Participation in activities to support regulatory agency inspections is required.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills and share knowledge with others.

Preferred Qualifications:

Experience in sterile injectable manufacturing, aseptic processing, and facility qualification.

Experience with the following microbiological testing and procedures:

• Sterility testing and method suitability testing per USP <71>
• Acceptance testing and use of biological indicators.