Stability Analyst

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-/)

Position Summary

The Stability Analyst 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.

The role is essential to assure the Petersburg site's Stability Program complies with applicable regulatory requirements and International Council for Harmonization (ICH) guidelines.

Responsibilities of the position include working cross-functionally to establish and maintain the stability program at Civica Petersburg. Responsibilities also include but are not limited to the generation, review and/or approval of policies, procedures, reports, protocols, investigation, change controls and other records necessary for the stability program.

Essential Duties and Responsibilities

• Work across functions to support the development and maintenance of the stability program at Civica Petersburg.
• Author stability protocols for new drug products and annual commitment batches, as per current procedures and regulatory requirement.
• Build plans for ensuring stability commitments are met.
• Support the shipment of samples to the appropriate external testing facilities.
• Acts as primary contact with Contract laboratories to coordinate and monitor stability protocols and testing schedules.
• Responsible for assessing stability requirements related to changes.
• Participate or lead stability investigations.
• Track sample receipt, testing and obtain results and raw data from contract labs.
• Build and manage stability data in the LIMS system.
• Supports Annual Product Quality Reviews and Annual Reports by providing relevant stability reports as needed.
• Support overall sample management and Quality Control Operations as needed.
• Compile and evaluate stability metrics, trend data and report to Management.
• Ensure that all aspects of the handling, stability samples at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
• Practice and promote a safety and quality mindset and a quality excellence approach to all activities.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor's degree in a scientific discipline with a minimum of 8 years Quality/CGMP experience in the pharmaceutical industry.
• Experience in managing stability studies.
• Excellent written/oral communication skills with a strong discipline in Microsoft Programs is required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Ability to work autonomously within established guidelines, procedures, and practices.
• Committed to delivering high quality results, overcoming challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills and share learning.

Preferred Qualifications:

• Experience with Laboratory Information Management Systems (LIMS).