Site Director of Manufacturing
Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration’s shortage list. Manufacturing challenges and predatory pricing are both the cause and result.
Who suffers most? Patients.
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. Led by an experienced team of health care and pharmaceutical industry leaders.
Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent 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 is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”
Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs.
To find out more about how Civica’s innovative model is directly impacting patient care, click here to read a recent article from the New England Journal of Medicine.
Intro to Civica
Reporting to the Vice President of Operations, the Site Director of Manufacturing will develop and oversee the implementation of the manufacturing operation at the site including all manufacturing processes, technology, automation and process transfer, gap assessment, master batch record, operation readiness, and execution of manufacturing requirements. The Director of Manufacturing must communicate manufacturing process performance internally and externally. Develop and lead all aspects of the Civica’s Manufacturing team's contribution towards production management, process monitoring, investigations, impact assessment, new process training, equipment qualification and process improvements.
Essential Duties and Responsibilities:
The essential functions include, but are not limited to the following:
- Must have a strong understanding of pharmaceutical manufacturing and processes.
- Ensures manufacturing organization operates to meet the requirements of approved production plans at minimum costs within quality limits & consistent with FDA, cGMP, ISO & OSHA requirements
- Responsible for identifying opportunities to improve customer service, quality, safety performance, scrap minimization or otherwise reduce manufacturing costs by using effective management, cost control techniques and Lean Manufacturing.
- Must have the ability to take initiative without direct oversite.
- Provides monthly reports and ongoing measurement of site results and various work initiatives including but not limited to identifying progress, issues, corrective action status, etc. for any work streams or planned activities.
- Directs the manufacturing organization to permit appropriate individuals to exercise control over costs, product quality production & efficient utilization of capital resources & personnel.
- Develops and maintains solid working relationships with the community, government agencies, and customers.
- Inspires, mentors and guides employees toward excellence and continuous improvement.
- Consistently enforces all site policies, practices, procedures, and guidelines.
- Administers a program for safety, hygiene, and fire protection to safeguard the health and welfare of the personnel as well as to preserve the facilities.
- Performs other duties as assigned based on business needs.
- Conforms with and abides by all laws.
Minimum Qualifications (Knowledge, Skills, and Abilities):
- Bachelor’s degree in business or technical field in manufacturing, engineering or supply chain management.
- 10+ years of related work experience
- Ability to directly supervise employees who are managers/supervisors/professional staff in the manufacturing/production area and indirectly manage employees to achieve on-time, on-budget results.
- Prior manufacturing experience in pharmaceutical’s including sterile injectables
- Proven general leadership and production management experience.
- Understanding and experience applying Six Sigma Lean Manufacturing principles.
- Possess excellent negotiation and conflict resolution skills.
- Effective problem solving and interpersonal skills.
- Ability to establish and maintain good working relationships with all levels in the organization.
- Proficient in computer use including Microsoft Office.
- Excellent written and verbal communication skills with all levels of employees.