Job Description
About Civica:
In the last two decades, 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 alleviate chronic drug 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.
Position Summary
The Manager, Manufacturing Nested Filling will support daily operations and pharmaceutical production at Civica’s Petersburg, VA site. Responsibilities include leading the manufacturing team, overseeing equipment qualifications, and implementing process improvements. The ideal candidate will have a proven track record in a fast-paced Pharmaceutical Sterile Fill/Finish environment.
Essential Duties and Responsibilities:
- Lead the Prep and Fill Operations team to meet production schedules.
- Create standard operating procedures and ensure compliance with regulations.
- Identify opportunities for improving quality and reducing costs.
- Mentor Manufacturing Associates in Lean/Six Sigma methodologies.
- Conduct training and manage manufacturing documents.
- Perform investigations and lead corrective actions.
- Assist in new product introductions and tech transfer activities.
- Other duties as assigned.
Basic Qualifications and Capabilities:
- Bachelor’s degree with 8+ years in a cGMP production environment; or an Associate degree with 10 years of experience.
- 3+ years of supervisory experience in a sterile fill-finish facility.
- Strong writing, communication, and leadership skills.
- Experience in process improvement and Lean/Six Sigma projects.
- Self-directed with strong analytical skills.
- Ability to collaborate across functions and manage projects effectively.