Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration’s shortage list. Manufacturing challenges and predatory pricing are both the cause and result.
Who suffers most? Patients.
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Led by an experienced team of health care and pharmaceutical industry leaders.
Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines.
Civica is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”
Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs.
To find out more about how Civica’s innovative model is directly impacting patient care, click here to read a recent article from the New England Journal of Medicine.
Intro to Civica
The Associate Microbiologist will join the Civica, Inc. (“Civica”) organization and its newly forming team 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 the microbiology testing laboratory from onset of building the laboratory and initial qualification of equipment.
The role is essential to assure 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, the 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 verification of microbiological methods and method transfers.
- Participate in the development of training programs for microbiologist.
- Lead and/or participate in investigations related to laboratory operations and non-conforming results.
- Identify, 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 (up to 10%) may be required.
Basic Qualifications and Capabilities:
- Bachelor’s degree in a scientific discipline (microbiology degree preferred) with a minimum of 3 years Quality/cGMP experience in the pharmaceutical industry.
- Strong project management, organization, and execution skills.
- Microbiology testing and environmental monitoring experience.
- Participation in activities to support regulatory agency inspections 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.
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
Physical Demands and Work Environment:
While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. Specific vision abilities required by this position include color vision, close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.
The employee must have the ability to lift approximately 50 lbs, stand for 2 to 3 hours at a time, and walk long distances. Vision screening may be required.
The employee must have the capability to don gowning/PPE for entry into the aseptic core and supporting areas for extended periods of time. This will include standing, bending, reaching, kneeling, etc.