Manager Manufacturing – Nested Fill – 2nd shift

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. The organization prioritizes patient interests and has expanded its mission to include affordable medications at retail pharmacies through CivicaScript.

Recently, Civica announced plans to produce affordable biosimilar insulin, ensuring consistent availability for those in need. Long- and short-acting insulins will be priced at no more than $30 per vial and $55 for a pack of five pens.

For more information, visit www.civicarx.org.

Job Description

The Manager, Manufacturing, Nested Fill will support daily operations and pharmaceutical production at Civica’s Petersburg, VA site. Responsibilities include equipment qualifications, process improvements, and leading a manufacturing team to ensure efficient, compliant production of quality injectable products.

This role involves overseeing 2nd shift operations, managing equipment, supporting new product introductions, and training staff. The ideal candidate will have a proven track record in a fast-paced Pharmaceutical Sterile Fill/Finish environment.

Essential Duties and Responsibilities:

• Participate in new equipment and process qualifications under the Director of Manufacturing’s guidance.
• Create standard operating procedures and specifications for manufacturing processes.
• Ensure compliance with production plans, quality limits, and regulatory requirements.
• Identify opportunities for improving customer service, quality, and cost reduction.
• Mentor Manufacturing Associates in statistical tools and Lean/Six Sigma methodologies.
• Utilize scientific methods for investigations and root cause analyses.
• Lead corrective and preventive actions (CAPA) projects to completion.
• Act as a subject matter expert in manufacturing equipment and processes.

Minimum Qualifications:

• 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, documentation, and interpersonal skills.
• Experience in process improvement and Lean/Six Sigma projects.
• Self-directed with strong analytical and problem-solving abilities.
• Ability to collaborate across functions and manage projects effectively.

PandoLogic. Keywords: Manufacturing Manager, Location: Petersburg, VA – 23803, PL: 595289445