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 CivicaScript, 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 patient care, click here to read a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
Video Intro to Civica: https://vimeo.com/646267406
In this critical role you will be responsible for all engineering project management, construction, and oversight of industry trade partners to deliver various capital projects at the Civica Petersburg facility. Will serve as the project manager for critical projects. Leads cross functional teams in the coordination and planning of projects from spending approval development to project closeout. Assuring that the engineering, construction, integrated commissioning, qualification and validation (CQV) are prepared for compliant commercial launch.
- Establishing safety culture and demonstrating safety by example
- Determining project objectives, consistent with company priorities and policies
- Leads project team including external contractors and coordinates their tasks through all project phases
- Ensures necessary communication within the project team (meetings, reporting) and coordinates interfaces outside of the project team with stakeholders, subject matter experts and customers
- Generates project execution plans including procurement strategies of outside services and materials. Leads vendor selection and contract negotiations
- Develops project staffing plans with all stakeholders ensuring adequate internal participation for the project scope
- Provides management direction in relation to project scope to ensure business need is met
- Leads qualification tasks (plan, controlling and reporting) in coordination with the Engineering and Quality organizations according to valid SOP's and issues plant documentation according to site engineering requirements
- Manages external relationships as it pertains to project scope including government authorities
- Responsible for the management of capital projects greater than potentially $25 million
- Provides technical expertise in SME area to include training junior level engineers or technical staff
- Leading contract partner evaluation and selection process
- Reviewing and approving cost estimates and establishing check and balance system
- Establishes policies for major projects, interprets, executes, and recommends modifications to company-wide policies
- Assist in verification procurement strategy, selection, and implementation
- Maintain technical skills in the latest techniques for project management and pharmaceutical processing technology
- 10+ years related engineering experience with 7+ years managing capital projects required OR equivalent, including 4+ years' experience the pharmaceutical, biotech, or medical device operations
- 3+ years of leadership experience; with ability to lead and develop a high-performing team
- Demonstrated knowledge of cGMPs and FDA requirements required
- Demonstrated ability to lead and develop a high performing workforce
- Previous operational readiness /project management/start-up experience
- Minimum of a Bachelor of Science (BS) Degree in engineering or related discipline from a fully accredited institution.
- Excellent oral and written communication skills, including presentations
- Experience in a pharmaceutical/FDA-regulated manufacturing environment
- Solid working knowledge of cGMP and facility/equipment validation requirements
- Demonstrate commitment to values-based leadership and achieving objectives in a manner that is supportive of the client's values and leader behaviors
- Ability to write clearly, concisely, and persuasively in a professional environment
- Capacity to interact effectively with all levels of the organization