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Manufacturing Manager

2 months ago

Washington, Washington, D.C., United States 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.

We are a collaborative effort between health systems and philanthropies, with a team of experienced healthcare and pharmaceutical industry leaders. Our goal is to create a more sustainable and equitable pharmaceutical supply chain.

Job Summary

The Manufacturing Manager - Sterile Fill/Finish will play a critical role in the facility start-up at our Civica Rx Petersburg, VA site. This position will be responsible for supporting daily manufacturing operations and ensuring the timely production of pharmaceuticals.

The ideal candidate will have a strong background in cGMP production, with experience in sterile fill-finish facilities and supervisory experience in GMP manufacturing environments. They will be responsible for leading the Prep and Fill Operations team to execute daily and weekly production schedules, developing and creating standard operating procedures, and ensuring compliance with FDA, cGMP, ISO, and OSHA requirements.

Key Responsibilities
  • Lead the Prep and Fill Operations team to execute daily and weekly production schedules to meet operations objectives.
  • Develop and create standard operating procedures, specifications, and other forms of governing documents to delineate manufacturing process requirements.
  • Ensure that the Manufacturing organization operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.
  • Responsible for identifying opportunities to improve customer service, quality, safety performance, scrap minimization, or otherwise reduce manufacturing costs.
  • Mentors, coaches, and teaches Manufacturing Associates in the use of 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. Identify and address any potential quality issues.
  • Perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Manufacturing.
  • Identify corrective and preventive actions (CAPA), lead project to completion within project timelines. Verify effectiveness of CAPA by post-project data collection and analysis.
  • Demonstrated ability to act as subject matter expert in manufacturing equipment build and function, as well as in 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 must be able to take ownership of and follow through on assigned projects.