Manufacturing Manager
3 weeks ago
About 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 of essential medicines.
Civica Rx has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.
The Manager, Manufacturing, Nested Fill will play a key role in the facility start-up with primary responsibilities focused on supporting daily manufacturing operations and the timely production of pharmaceuticals at the Civica Rx Petersburg, VA site. The 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.
Key Responsibilities:
- Under the Director of Manufacturing's direction, actively participate in new equipment and process qualifications.
- 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.
- 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.
- Responsible for identifying opportunities to improve customer service, quality, safety performance, scrap minimization, or otherwise reduce manufacturing costs by using effective project management, cost control techniques, and Lean Manufacturing.
- Mentors, coaches, and teaches Manufacturing Associates in the use of statistical tools, Lean/Six Sigma methodologies, and change management/control techniques to ensure timely completion of projects at the expected results.
- 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.
- 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.
Requirements:
- Bachelor's degree with 8+ years of demonstrated ability in a cGMP production environment. An Associate degree and 10 years of cGMP production experience may be considered.
- Experience in a sterile fill-finish facility. 3+ years' supervisory experience in a GMP manufacturing environment.
- Strong writing and documentation skills.
- Strong interpersonal, collaboration, communication, and leadership skills.
- Experience in a process improvement environment, including change management, optimizing process flow and participating in Lean/Six Sigma project teams.
- Self-directed with effective analytical and problem-solving skills.
- Interact with other functions and must be able to take ownership of and follow through on assigned projects.
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. An experienced team of health care and pharmaceutical industry leaders leads the organization.
Today, more than 55 health systems have joined Civica Rx. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica Rx has also supplied 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 Rx has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.
Civica Rx has announced plans to develop, manufacture and deliver affordable biosimilar insulin. The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses.
Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.
Learn more about Civica Rx's plans and progress at
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