Manufacturing Manager

2 days ago


US Petersburg VA USA Civica Rx Full time
About Civica Rx

Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to essential medications at affordable prices.

Job Summary

The Manager, Manufacturing Nested Filling, will play a critical role in the facility start-up at our Civica Petersburg, VA site. This position will lead the Prep and Fill Operations team to execute daily and weekly production schedules, ensuring efficient, cost-effective, safe, and compliant production of quality injectable products.

Key Responsibilities
  • Develop and implement standard operating procedures, specifications, and governing documents to meet qualification, compliance, and business requirements.
  • Ensure the Manufacturing organization operates within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.
  • Identify opportunities to improve customer service, quality, safety performance, scrap minimization, or reduce manufacturing costs using effective project management, cost control techniques, and Lean Manufacturing.
  • Mentor and train Manufacturing Associates in statistical tools, Lean/Six Sigma methodologies, and change management/control techniques.
  • Conduct investigations, root cause analyses, and impact assessments to resolve deviations/discrepancies related to Manufacturing.
  • Lead project teams to implement corrective and preventive actions (CAPA) and verify effectiveness through post-project data collection and analysis.
Requirements
  • Bachelor's degree with 8+ years of demonstrated ability in a cGMP production environment. An Associate degree and 10 years of cGMP production experience may be considered.
  • Experience in a sterile fill-finish facility with 3+ years' supervisory experience in a GMP manufacturing environment.
  • Strong writing and documentation skills, as well as strong interpersonal, collaboration, communication, and leadership skills.
  • Experience in a process improvement environment, including change management, optimizing process flow, and participating in Lean/Six Sigma project teams.

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