Manufacturing Manager

19 hours 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 Rx Petersburg, VA site. This position will lead the Prep and Fill Operations team to execute daily and weekly production schedules, ensuring timely production of pharmaceuticals while maintaining quality and compliance with FDA, cGMP, ISO, and OSHA requirements.

Key Responsibilities
  • Lead the Prep and Fill Operations team to achieve efficient, cost-effective, safe, and compliant production of quality injectable products.
  • Develop and create standard operating procedures, specifications, and other governing documents to delineate manufacturing process requirements.
  • Ensure the Manufacturing organization operates to meet approved production plans at minimum costs within established quality limits.
  • 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, coach, and teach Manufacturing Associates in statistical tools, Lean/Six Sigma methodologies, and change management/control techniques.
  • Conduct training and ensure staff training is documented, current, and follows cGMP requirements.
  • Assist in the revision and management of manufacturing documents, such as Batch Records and SOPs, and identify and address potential quality issues.
  • Perform investigations, root cause analyses, and impact assessments to support timely resolution of deviations/discrepancies related to Manufacturing.
  • Identify corrective and preventive actions (CAPA), lead projects to completion within project timelines, and verify effectiveness by post-project data collection and analysis.
  • Demonstrate expertise in manufacturing equipment build and function, as well as manufacturing processes, including aseptic filling, isolator/RABs technology, and packaging.
  • Assist R&D and MSAT on new product introduction and tech transfer activities to meet commercial demand.
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. 3+ years' supervisory experience in a GMP manufacturing environment.
  • Strong writing and documentation skills.
  • 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.
  • Self-directed with effective analytical and problem-solving skills.
  • Interact with other functions and take ownership of and follow through on assigned projects.

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