Manufacturing Manager
4 weeks ago
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.
-
Manufacturing Manager
4 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica Rx:A leading social welfare organization, Civica Rx, was established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. The organization has supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile...
-
Process Engineer
4 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout 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 do what's in the best interest of patients.We are searching for a Process Engineer with knowledge in pharmaceutical drug product manufacturing, specifically in the areas of...
-
Manufacturing Supervisor
4 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeJob DescriptionThe Manufacturing Supervisor will play a key role in the facility start-up at Civica Rx's Petersburg, VA site. This position will lead day-to-day Cartridge Visual Inspection and Pen Assembly Operations, overseeing equipment, supporting new product introductions, and ensuring timely production of pharmaceuticals.Key Responsibilities:Lead the...
-
Manufacturing Manager
4 weeks ago
Petersburg, Virginia, United States Civica Rx Full timeAbout 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 experienced health care and pharmaceutical industry leaders is committed to ensuring the consistent availability of affordable medications.Job Description:The Manager,...
-
Lead Manufacturing Specialist
2 weeks ago
Petersburg, VA, United States Civica Rx Full timeRace to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages...
-
Manufacturing Manager
4 weeks ago
Petersburg, Virginia, United States civica Rx Full timeAbout the RoleCivica Rx is seeking a highly skilled Manufacturing Manager to join our team at our Petersburg, VA site. As a key member of our manufacturing team, you will play a critical role in supporting daily operations and ensuring the timely production of pharmaceuticals.The ideal candidate will have a strong background in cGMP production, with...
-
Manufacturing Manager
4 weeks ago
Petersburg, Virginia, United States Civica Rx Full timeJob SummaryCivica Rx is seeking a highly skilled Manufacturing Manager to join our team at the Civica Petersburg, VA site. The successful candidate will be responsible for leading the manufacturing team to achieve efficient, cost-effective, safe, and compliant production of quality injectable products.Key ResponsibilitiesDevelop and support the Manufacturing...
-
Manufacturing Manager
1 month ago
Petersburg, United States Sterling Life Sciences Full timeJob Title: Manager of Manufacturing, Science and TechnologyA unique opportunity exists for an exceptional individual to lead the transfer of sterile biologics production processes and technologies from R&D into site operations.Key Responsibilities:Develop and implement biologics process control strategy documents, technology transfer change controls,...
-
Manufacturing Manager
4 weeks ago
Petersburg, Virginia, United States civica Rx Full timeJob SummaryCivica Rx is seeking an experienced Manufacturing Manager to lead our sterile fill-finish operations at our Petersburg, VA site. As a key member of our manufacturing team, you will be responsible for ensuring the timely production of high-quality injectable products while maintaining a safe and compliant work environment.Key...
-
Manufacturing Manager
1 month ago
Petersburg, United States Sterling Life Sciences Full timeJob OpportunityA unique chance exists for an exceptional individual to excel in the role of Manager of Manufacturing, Science and Technology.Our client, a leading pharmaceutical company, Sterling Life Sciences, is seeking a talented professional to bring added value to the team.Key Responsibilities:Lead the transfer of sterile biologics production processes...
-
Senior Manager of Operational Technology
4 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout 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. Established in 2018 by health systems and philanthropies, the organization has grown to include over 55 health systems, representing over 1,500 hospitals and 30% of all U.S. hospital beds.The...
-
Manufacturing Operations Manager
3 days ago
Petersburg, United States Civica Full timeJob Summary:We are seeking a highly skilled Manufacturing Operations Manager to lead our Pen Assembly and Visual Inspection team. The successful candidate will be responsible for executing daily and weekly production schedules, monitoring team productivity, and ensuring the quality of our products.Key Responsibilities:Lead the Pen Assembly and Visual...
-
Manufacturing Manager
4 weeks ago
Petersburg, Virginia, United States Civica Rx Full timeAbout 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 experienced healthcare and pharmaceutical industry leaders is committed to "doing what is in the best interest of patients."Job Summary:The Manager, Manufacturing Nested Filling...
-
Manufacturing Manager
4 weeks ago
Petersburg, United States Civica Rx Full timeAbout 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 are committed to working with healthcare stakeholders...
-
Manufacturing Manager
4 weeks ago
Petersburg, United States Civica Rx Full timeAbout 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...
-
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a social welfare organization established to reduce chronic generic drug shortages and related high prices in the United States. Our team of healthcare and pharmaceutical industry leaders is dedicated to ensuring quality generic medications are accessible and affordable to everyone.We have begun to supply the U.S. Department of...
-
Project Management Associate
4 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout 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 healthcare and pharmaceutical industry leaders is committed to doing what's best for patients.We've made significant progress in our mission, with over 55 health systems joining our...
-
Manager, Manufacturing, Science and Technology
2 months ago
Petersburg, United States Civica Rx Full timeAbout Civica: Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile...
-
Sterile Product Validation Manager
4 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeJob Description:The Validation Manager for Sterile Injectables will lead Aseptic Simulation Studies for Sterile Products and Bio-similar products at Civica Rx, Petersburg. This role will be responsible for designing and developing the Aseptic Process Simulation (APS) program for Aseptic and Biosimilar injectables.Key Responsibilities:Design and develop the...
-
Manager, Manufacturing
2 weeks ago
Petersburg, United States Civica Rx Full timeAbout Civica: Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile...