Manager, Manufacturing
2 months ago
About Civica
Civica 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. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines.
Civica recently announced plans to expand its mission, via a unit called Civica Script, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.
Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients." Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.
To find out more about how Civica's innovative model is directly impacting patientcare, click here to read a summary from the New England Journal of Medicine. )
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
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Job Description
The Manufacturing Manager will develop and support the Manufacturing team by participating in equipment qualifications, identifying and implementing process improvements through process monitoring, conducting investigations and impact assessments. Will provide new process training to the manufacturing team to achieve efficient, safe, and compliant production of quality injectable products according to the Civica culture and vision of what is in the best interest of the patient.
Essential Duties and Responsibilities:
Mentors, coaches, and teaches Manufacturing technicians to perform routine prep and filling activities for the cartridge line. Ensure that the Manufacturing organization operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements. Develop and create standard operating procedures, specifications, and other forms of governing documents to delineate manufacturing process requirements according to qualification, compliance, and business requirements. Under the Director of Manufacturing's direction, actively participate in new equipment and process qualifications. Responsible for identifying opportunities to improve customer service, quality, safety performance, scrap minimization by using effective project management, cost control techniques, and Lean Manufacturing. Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Manufacturing. Identify corrective and preventive actions (CAPA), lead project to completion within project timelines. Verify effectiveness of CAPA by post-project data collection and analysis. Use of statistical tools, Lean/Six Sigma methodologies, and change management/control techniques to ensure timely completion of projects at the expected results. Demonstrated ability to act as subject matter expert in manufacturing equipment build and function, as well as in manufacturing processes, including aseptic filling, isolator/RABs technology, and packaging.Minimum Qualifications (Knowledge, Skills, and Abilities) Bachelor's degree with 8+ years demonstrated ability in a cGMP production environment. Associate degree and 10 years of cGMP production experience or High School degree with 12 years of experience of cGMP production experience may be considered. Experience in a sterile fill finish facility. 2+ years of supervisory experience. Demonstrated excellence in oral and written communication. Preferred Qualifications: Experience with equipment qualification. Advanced experience in a process improvement environment including project management, change management and leading Lean/Six Sigma project teams. Lean Manufacturing/Six Sigma Green Belt Certification preferred. Position ID: 429Shift: 7:00 am – 3:30 pm. Monday through Friday.
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