Manager, Manufacturing – Pen Device Assembly

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.”

Recently, Civica has expanded its mission to include affordable biosimilar insulin, ensuring consistent availability for those in need. Learn more at www.civicarx.org.

Job Description

The Pen Device Assembly Manager will oversee the assembly of medical pen devices at Civica’s Petersburg, VA site, ensuring quality and compliance. This role requires strong manufacturing experience, particularly in medical devices, and excellent leadership skills.

Essential Duties:

• Manage daily assembly operations
• Develop production schedules
• Optimize processes for efficiency
• Monitor production metrics
• Ensure regulatory compliance
• Collaborate with Quality Assurance
• Train and develop team members
• Foster a culture of improvement
• Support new product development
• Prepare production reports

Basic Qualifications:

• Bachelor’s degree in a related field
• 5+ years in manufacturing management
• 8+ years in a cGMP environment
• Strong knowledge of FDA and ISO standards
• Excellent leadership skills
• Proficiency in lean manufacturing
• Experience with ERP systems

Preferred Qualifications:

• Experience with pen devices in a sterile environment