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 Manufacturing Lead’s primary responsibility is to coordinate the manufacturing team workload, operator deployment, and workflow on a daily basis to meet short-term departmental goals.
Monitor and support staff on the production floor, serve as the manufacturing team’s primary resource for problem solving, conflict resolution, and coordination.
Lead and develop manufacturing team in the efficient, cost effective, safe, and compliant production of quality injectable products according to the Civica culture and vision of what is in the best interest of the patient.
- Under the supervisor’s direction, lead the manufacturing team to execute daily and weekly production schedules to meet strategic department objectives.
- Conduct daily shift meetings to communicate current events, issues, and solicit team feedback.
- Monitor manufacturing team productivity and resolve immediate production cell assignment needs to facilitate efficiency. Coordinate the team’s break and lunch periods to minimize production downtime.
- Manage daily and weekly staffing requirements to account for absent personnel (PTO) to satisfy production needs. Coordinate overtime scheduling as needed.
- Monitor the inventory of raw materials, components, and production supplies. Report any quality issues and shortages to the supervisor to prevent production interruptions.
- Conduct training and ensure staff training is documented, is current, and follows cGMP requirements.
- Review batch records, cycle reports, and other manufacturing documentation to identify and address any potential quality issues.
- Perform and/or oversee batch accountability calculations and final batch quantity confirmations.
- Provide immediate support in the identification and documentation of deviations and discrepancies on the manufacturing floor.
- Support cross-departmental activities including maintenance, qualification, testing, and investigational activities.
- Assist in the development and update of manufacturing procedures and training materials.
Key Performance Indicators
- Daily/weekly schedule conformance
- Team performance/safety
- Quality compliance
- Production output/cost management
- A minimum of 4 years’ experience in a GMP manufacturing environment or 2 years’ leadership experience in a GMP manufacturing environment with associate degree, or equivalent experience and knowledge. Aseptic parenteral manufacturing experience preferred.