Job Description:
About Civica:
Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.
Who suffers most? Patients.
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent 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 of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."
Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.
More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.
Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.
Learn more about Civica's plans and progress 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.
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