Manufacturing Specialist – Line Lead 1st Shift

Job Description

About Civica:

In the last 20 years, the U.S. has faced a significant rise in shortages of essential generic injectable medications, with over 300 reported shortages. This crisis stems from “race to the bottom” pricing, manufacturing challenges, and predatory pricing, ultimately impacting patients the most.

Civica, a 501(c)(4) social welfare organization founded in 2018 by various health systems and philanthropies, aims to combat these shortages and high prices. With over 55 health systems representing 1,500 hospitals, Civica also supplies essential medicines to the U.S. Department of Veterans Affairs and the Department of Defense. Their guiding principle is to “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission to include reducing pharmacy costs through its sister organization, CivicaScript, and is developing affordable biosimilar insulin to support those in need.

Position Summary

The Manufacturing Specialist Line Lead will oversee daily manufacturing activities at the Civica Petersburg, VA site, ensuring timely pharmaceutical production. Responsibilities include leading production, collaborating with cross-functional teams, training new staff, and managing manufacturing investigations.

Essential Duties and Responsibilities

• Lead daily production activities, aligning personnel and resources.
• Collaborate with various teams to meet production needs.
• Train Manufacturing Operators on process equipment.
• Assist in new product introductions and tech transfers.
• Conduct manufacturing investigations and manage documentation.
• Provide technical support to production teams.
• Support regulatory inspections.
• Adapt to changes in production schedules.

Basic Qualifications

• 4+ years in biopharmaceutical manufacturing in a GMP environment.
• Associate’s degree or higher in a related field preferred.
• Experience with sterile fill-finish manufacturing.
• Knowledge of GMP and regulatory requirements.
• Detail-oriented with strong documentation skills.
• Ability to work autonomously and in teams.
• Experience in process improvement and ERP systems.
• Strong communication and collaboration skills.
• Experience as a shift lead and training others.

Preferred Qualifications

• Knowledge of high-speed aseptic filling technology.
• Experience with single-use components in drug formulation.
• Proficiency in Microsoft Office Suite.

Learn more about Civica at www.civicarx.org