Manufacturing Specialist Line Lead

6 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 team of healthcare and pharmaceutical industry leaders works tirelessly to ensure the consistent availability of essential medications.

Job Summary

The Manufacturing Specialist Line Lead will play a critical role in the facility start-up at our Civica Rx Petersburg, VA site. This position will lead daily manufacturing activities on the floor, perform routine equipment and production activities, and ensure the timely production of pharmaceuticals.

Key Responsibilities

  • Lead the day-to-day production activities on the line, aligning and scheduling personnel and resources to meet daily and weekly production demands.
  • Collaborate with cross-functional teams to meet production needs, including Manufacturing, Quality Operations, Environmental Health and Safety.
  • Support the onboarding and technical training of Manufacturing Operators on process equipment, including high-speed fill lines and Terminal Sterilizers.
  • Assist R&D and MSAT on new product introduction and tech transfer activities to ensure a steady stream of products to meet commercial demand.
  • Initiate and complete manufacturing investigations, including root cause analysis and product impact assessment.
  • Provide technical expertise and support to production teams, addressing issues and challenges as they arise.

Requirements

  • A minimum of four+ years' experience in biopharmaceutical manufacturing in a GMP environment.
  • An associate's degree or higher in Pharmaceutical Sciences, Biology, or a related field is preferred.
  • Experience with sterile fill-finish manufacturing and knowledge of GMP, regulatory requirements, and industry best practices.
  • Detailed-oriented with a focus on accuracy in creating and updating production documents.
  • Ability to work autonomously and within established guidelines, procedures, and practices.

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 healthcare and pharmaceutical industry leaders works tirelessly to ensure the consistent availability of essential medications.

Our Mission

At Civica Rx, our mission is to reduce chronic generic drug shortages and related high prices in the United States. We believe that everyone deserves access to affordable medications, and we are committed to making that a reality.

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