Manufacturing Lead

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-/)

Watch this video to learn more about Civica!

Job Purpose

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.

Major Accountabilities

• 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

Education/Experience

• A minimum of 4 years experience in a GMP manufacturing environment OR 2 years' leadership experience in a GMP manufacturing environment with an associate degree, or equivalent experience and knowledge
• Aseptic parenteral manufacturing experience preferred

PI193417021