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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 established to reduce 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

We are seeking a highly experienced Manufacturing Manager - Technical Transfer and Process Support to lead the technical transfer and process support activities for New Product Introduction at our Civica Rx Petersburg site. As a key member of our MSAT team, 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 Technical Transfer and Process Support: Develop and execute technical transfer plans, process control strategies, and technology transfer change controls to ensure seamless transfer of production processes and technologies from R&D into site operations.
  • Process Stewardship: Responsible for process stewardship throughout the lifecycle management of commercial manufacturing processes, including initial manufacturing batch record creation, protocol development, authoring, training, and execution support, process troubleshooting, and on-the-floor hyper care as needed.
  • Process Performance Qualification (PPQ): Design and execute PPQ plans to demonstrate manufacturing process performance and initiate commercial manufacturing.
  • Product Technical Lifecycle Management: Oversee product technical lifecycle management, including process control strategy, process/yield improvement, process knowledge management, batch deviations, and ensuring accuracy of regulatory CMC registration detail.
  • Regulatory Compliance: Support product pre-approval inspection, including direct interaction with regulatory agencies during site inspections, and prepare and review cGMP documents as needed.
  • Collaboration and Leadership: Work closely with operations and validation teams to prepare aseptic core packages for submissions, and lead cross-functional tech transfer teams comprising of R&D, QA, QC, Regulatory Affairs, and operations.
  • Technical Leadership: Provide technical leadership for the rapid resolution of technical issues impacting supply through product performance investigations and use of root cause analysis (RCA) tools and appropriate Corrective and Preventative Actions (CAPA).

Requirements

  • Bachelor of Science Engineering or a similar technical degree. A postgraduate degree is desired, but not required.
  • Minimum of +6 years' experience in technical transfer and process validation.
  • Experience working in FDA-regulated environments.
  • Experience working in parenteral facility operations settings.
  • Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization.
  • Strong interpersonal, collaboration, and leadership skills.