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-/)

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 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 has recently begun to commercialize biosimilars to ensure affordability, starting with a commitment to develop and launch affordable insulin vials and pens at transparent, low prices.  

Essential Duties and Responsibilities:

The person in this role must be able to evaluate analytical results for scientific merit and cGMP compliance, critically review analytical method validation documents, participate in GMP laboratory audits, and manage and store data per FDA requirements.

This position requires management of analytical activities at contract development and manufacturing organizations (CDMOs) to enable development and approval of new biosimilar insulin products at Civica. This position requires a person with the ability to interact effectively with people of diverse backgrounds and organizational roles while working from a remote location. Effective verbal communication including excellent listening skills are required.

The person in this role must make accurate technical decisions with support from colleagues, while providing direction and oversight for contract laboratories or partner organizations. The person in this role must be proactive regarding timelines and manage expenditures wisely. Finally, this position requires the ability to write technical documents for regulatory filings with FDA.

Basic Qualifications and Capabilities:

Experience working in a Quality Control role supporting development of biologic products is required.  Technical and regulatory document writing ability and effective verbal/listening skills are also required.

Technical understanding of drug substance impurity (ie host cell proteins, host cell DNA) method development, validation, and testing to current FDA and industry expectations is preferred. Technical expertise and experience with cell-based and binding (SPR) bioassays for biologic product development is also preferred.

Experience with development and qualification of mass spectrometry and other biophysical characterization methods would be an added qualification but is not central to this position.

Ideally, the candidate would also have experience and personal knowledge of FDA expectations for analytical studies required for biosimilar BLA filings. 

Preferred Qualifications:

A minimum of 6 years experience in a Quality Control role supporting biologics product development is required. 8 years experience is preferred. Technical understanding of drug substance impurity (host cell impurity) method development and/or similar experience and expertise in bioassays (cell-based and binding) is preferred.

A minimum of a Master’s degree in Chemistry, Molecular Biology, or related technical field.

Physical Demands and Work Environment:

Position is remote with 40% travel required.

Position: #524