Project Manager (151) at Civica in Petersburg, Virginia

Job Description:

About Civica:



Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.


Shortages put patients at risk and waste hospital resources.


Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.


Civica's mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.


Civica's new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.


The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica's work to manufacture and distribute affordable medications. The Foundation's first commitment is to support Civica's efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.


Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.


Join us. Learn more at www.civicarx.org




Job Description



This position will play a crucial role in the startup of Manufacturing at the Petersburg, VA site. The Project Manager is responsible for overseeing the planning, execution, and completion of projects. Strong knowledge of project management methodologies, biologics processes and regulatory pathways is required to be successful in this role.



Essential Duties and Responsibilities:

• Lead end-to end project management, including initiation, planning, execution, monitoring and project closure.


• Define scope, objectives, deliverables, and timelines in collaboration with stakeholders.


• Develop comprehensive project plans and resource loaded schedules to ensure on-time implementation.


• Create project dashboards for the monitoring of progress, identifying risk and implementing mitigation strategies.


• Build strong relationships with stakeholders and effectively communicate project updates and challenges.


• Manage project-related meetings, document meeting minutes, decisions, and action items.


• Prepare project status reports and present to site and above-site leadership.


• Conduct thorough project reviews to identify lessons learned and areas for continuous improvement.


• Promote a culture of continuous improvement throughout the site, fostering innovation and best practices.

• Bachelor's degree and 7+ years of project management experience. PMP certification preferred.


• Continuously looking for opportunities to learn, build skills, and share knowledge with others.


• Must be versed in Project Management tools and must have knowledge of related disciplines.


• Experience working in cGMP environments that meet FDA, ICH guidelines, local regulations, and industry best practices.


• Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work. Start-up experience preferred.


• Proven track record of being self-motivated and capable of working with cross-functional teams while remaining positive towards project challenges.


• Advanced computer skills with working knowledge of MS Project, Office, Word, Excel, PowerPoint, etc.


• Excellent oral and written communication skills, including presentations.