Associate Microbiologist

About Civica

 

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. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third 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 recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.

Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.

To find out more about how Civica's innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)

To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

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.
  
  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 Acceptance testing and use of biological indicators

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