Manufacturing Manager

4 weeks ago


US Petersburg VA USA Civica Rx Full time
About the Role

Civica Rx is seeking a highly skilled Manufacturing Manager to lead the technical transfer and process support activities for New Product Introduction at our Petersburg site. Reporting to the Director, MSAT, you will work closely with our manufacturing and engineering teams to develop, transfer, execute, and improve technical transfer processes to meet project and business objectives.

Key Responsibilities:

  • Lead the transfer of production processes and technologies from R&D into site operations.
  • Develop process control strategy documents, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D.
  • Responsible for process stewardship throughout lifecycle management of commercial manufacturing processes.
  • Design Process Performance Qualification (PPQ) plans to demonstrate manufacturing process performance.
  • Oversee product technical lifecycle management, including process control strategy, process/yield improvement, and regulatory CMC registration detail.

Requirements:

  • Bachelor of Science in Engineering or a similar technical degree.
  • Minimum of 6 years' experience in technical transfer and process validation.
  • Experience working in FDA-regulated environments and parenteral facility operations settings.
  • Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization.

About Civica Rx

Civica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Our team of experienced health care and pharmaceutical industry leaders is dedicated to Do What Is in the Best Interest of Patients.


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