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 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.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

Position Summary

Reporting to the Chief R&D Officer, the Project Manager will support implementation of autonomous Product Development initiatives for Civica. This includes tracking/coordinating end-to-end activities from early research and development through regulatory submission and ANDA approval. This role will offer support for products being developed for Civica by contract development organizations, technical transfer into commercial testing site and the Civica Petersburg manufacturing facility. Additionally, this role also involves management of projects for CivicaScript and other special R&D projects supporting the Civica portfolio as required.

Essential Duties and Responsibilities

• Manage multi-functional and technical project teams to implement sterile injectable drug products developed and transferred to the manufacturing facility and other products such as oral solid dosage and biologic products currently under development. Projects may include product development, analytical development, final product technical transfer, process qualifications/validations, vendor oversight, cost tracking, and miscellaneous technical and project planning support.
• Management oversight for the creation of R&D laboratory, including support for the purchase of the laboratory equipment and instruments, etc.
• Development and tracking of detailed project plans.
• Manage project costs and report on project financials.
• Provide project risk management oversight.
• Routine reporting to team members, management and others.
• Directs project(s) and project teams ensuring all necessary activities occur as planned.
• Coordinate scheduling of project activities to meet deliverables.
• Utilize expertise and experience to resolve issues.
• Identify resource issues and utilize effective communication/leadership to ensure that satisfactory resolution occurs.
• Maintain close contact with both Civica and external partner representative(s) through meetings, site visits, teleconferences, and other forums to ensure that issues are addressed, and project timeline activities are met.
• Serves as primary contact and communication link between Civica and external project partners and companies.
• Meet regularly with project team members to understand technical, quality and financial issues as related to the project(s).
• Prepare and present project updates to Civica executive and advisory committees, as necessary.
• Solicit other projects that are aligned with Civica goals & objectives.
• Perform other duties as assigned.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• 8-20 years of experience in the pharmaceutical manufacturing and GMP industry.
• 3+ years of project management experience in the pharmaceutical industry relating to product development and launch, business process optimization, regulatory submission and/or regulatory compliance, and/or quality assurance.
• BS/BA in a relevant discipline, e.g. project management, engineering, R&D, operations management, or similar is required.
• Experience in product development and pharmaceutical operations in cGMP environment.
• Knowledge and application of a disciplined project management process (Six Sigma and Project Management Professional certifications a plus)
• Enjoys galvanizing teams around projects effectively
• Thrives on being tenacious and completing projects
• Ability to work with a variety of technical disciplines.
• Knowledge of and significant proficiency in project management software, such as Microsoft Project and others.
• Solid analytical and strategic capabilities and business acumen along with demonstrated work ethic, integrity, and professional conduct.
• Demonstrated ability to effectively communicate and negotiate a diversity of issues.
• Strong interpersonal and communication skills, both verbally and written, at all levels within Civica and external partner organizations.
• Ability to effectively collaborate with others to achieve team goals and expectations.
• Effective time management and prioritization skills.
• Outstanding organization skills and attention to detail.
• Self-starter, mature, independent and dependable.
• Ability to work in a fast-paced environment under pressure, able to multi-task and obtain results.
• Ability to maintain high degree of confidentiality and use of appropriate discretion and independent judgment.