Manufacturing Manager

2 weeks ago


US Petersburg VA USA Civica Rx Full time
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 mission is to ensure that patients have access to affordable, high-quality medications. We achieve this by developing and manufacturing essential generic medications, partnering with healthcare systems and pharmacies to reduce costs, and advocating for policy changes that promote affordable access to medications.

Job Description:Manager, Manufacturing, Science and Technology (MSAT)

The Manager, MSAT will lead the technical transfer and process support activities for New Product Introduction for the Civica Rx Petersburg site. Reporting to the Director, MSAT, you will work with our manufacturing and engineering teams and lead technology transfers. You will collaborate closely with R&D and 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, process knowledge management, batch deviations, and regulatory CMC registration detail.
  • Support product pre-approval inspections and interact with regulatory agencies during site inspections.
  • Prepare and review cGMP documents, including batch records, technical protocols, and reports.
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.
  • Strong interpersonal, collaboration, and leadership skills.

  • Manufacturing Manager

    4 weeks ago


    US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 affordable, high-quality medications.Job DescriptionThe Manager, Manufacturing, Nested Fill will play a critical role in the facility...

  • Manufacturing Manager

    4 weeks ago


    US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 mission is to ensure that patients have access to affordable, high-quality medications. We achieve this by developing and manufacturing essential...

  • Manufacturing Manager

    3 weeks ago


    US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 Description:Manager, Manufacturing, Science and Technology (MSAT)The MSAT Manager will lead...


  • US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 SummaryWe are seeking a highly skilled Manufacturing Manager to join our team at our...

  • Manufacturing Manager

    17 hours ago


    US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 SummaryThe Manager, Manufacturing Nested Filling, will play a critical role in the facility...


  • US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 SummaryThe Manager, Manufacturing Nested Filling, will play a critical role in the facility...

  • Manufacturing Manager

    2 weeks ago


    US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 SummaryThe Manager, Manufacturing Nested Filling, will play a critical role in the facility...

  • Manufacturing Manager

    4 weeks ago


    US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 SummaryThe Manager, Manufacturing Nested Filling, will play a critical role in the facility...

  • Project Manager

    2 weeks ago


    US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 mission is to ensure that quality generic medications are accessible and affordable to everyone.Job DescriptionThis position will play a crucial...


  • US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 affordable, high-quality medications.Job SummaryWe are seeking a highly experienced Manufacturing Supervisor to join our team at our...


  • US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 affordable, high-quality medications.Job SummaryWe are seeking a highly experienced Manufacturing Supervisor to join our team at our...


  • US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 Description:Manager, Manufacturing, Science and Technology (MSAT)The MSAT Manager will lead...


  • US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 experienced healthcare and pharmaceutical industry leaders is committed to ensuring that quality generic medications are accessible and affordable to everyone.We have established...


  • Sterling, ND , USA, United States Midwest Manufacturing Full time

    Job SummaryThis position is responsible for learning all production, management, and supervision operations of the Midwest Manufacturing production facility.Key ResponsibilitiesEnsure efficient production processes and timely order fulfillment.Set and evaluate production quotas, both quantity and quality.Lead and manage team members in your area.Collaborate...


  • US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 mission is to ensure that patients have access to affordable, high-quality medications.Job SummaryThe Supervisor, Manufacturing Prep and Fill...


  • US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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 experienced healthcare and pharmaceutical industry leaders is committed to ensuring that quality generic medications are accessible and affordable to everyone.Job DescriptionThe...


  • US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Founded in 2018 by health systems and philanthropies, Civica Rx has grown to include over 55 health systems, representing over 1,500 hospitals and 30% of all U.S. hospital beds.Our mission...


  • US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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.Job SummaryThe Manufacturing Specialist Line Lead will play a critical role in the facility start-up at our Civica Rx...


  • US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica 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...


  • US-, Petersburg, VA, USA Civica Rx Full time

    Job Title: Manufacturing SupervisorCivica Rx is seeking a highly skilled Manufacturing Supervisor to lead our sterile fill/finish operations team at our Petersburg, VA facility. As a key member of our manufacturing team, you will be responsible for overseeing daily production schedules, managing team productivity, and ensuring the timely production of...