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 combat chronic drug shortages and high prices. With over 55 health systems representing 1,500 hospitals, Civica 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. Insulin will be priced at no more than $30 per vial and $55 for a pack of five pens.

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Position Summary

The Manufacturing Specialist Line Lead (2nd Shift) will oversee daily manufacturing activities at the Civica Petersburg, VA site, ensuring timely pharmaceutical production. This role involves collaboration with cross-functional teams, equipment operation, and training new personnel.

Essential Duties and Responsibilities

• Lead daily production activities, aligning personnel and resources.
• Collaborate with various teams to meet production needs.
• Support onboarding and training of Manufacturing Operators.
• Assist in new product introductions and tech transfer activities.
• Conduct manufacturing investigations and root cause analyses.
• Revise and manage manufacturing documents.
• Provide technical support to production teams.
• Support regulatory inspections.
• Adapt to changes in production schedules as needed.

Basic Qualifications

• 4+ years of experience in biopharmaceutical manufacturing in a GMP environment.
• Associate's degree or higher in Pharmaceutical Sciences, Biology, or related field preferred.
• Experience with sterile fill-finish manufacturing.
• Knowledge of GMP and regulatory requirements.
• Detail-oriented with a focus on accuracy.
• Ability to work autonomously within established guidelines.
• Experience in process improvement and change management.
• Familiarity with ERP systems.
• Strong communication and collaboration skills.
• Experience as a shift lead and training others.

Preferred Qualifications

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

PandoLogic. Keywords: Manufacturing Technician, Location: Petersburg, VA - 23803, PL: 594793964

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