Senior Project Manager (378)

About Civica: Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high.

Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results. Who suffers most? Patients. Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St.

Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) 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.

They represent over 1,500 hospitals and over 30 percent 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 of essential medicines. Since established, the 1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” Civica 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. More recently, Civica 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. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

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’s plans and progress 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. The ideal candidate will have a strong background in project management within the pharmaceutical industry, with a focus on capital projects related to manufacturing facilities, laboratories, and infrastructure. Essential Duties and Responsibilities:

Lead end-to end project management, including initiation, planning, execution, monitoring and project closure. Ensure adherence to timelines, budgets, and quality standards. Collaborate with stakeholders such as engineering, manufacturing, and quality to define scope, objectives, and deliverables.

Manage relationships with external vendors, contractors, and suppliers to ensure timely delivery of equipment, materials, and services. Develop comprehensive project plans and resource loaded schedules to ensure on-time implementation. Identify and mitigate project risks, proactively addressing issues to prevent delays or cost overruns.

Develop and manage project budgets, allocate resources effectively, and track expenses to ensure financial objectives are met. Create project dashboards for monitoring progress and communicating risks. 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. Basic Qualifications and Capabilities: Bachelor’s degree and 10 years of project management experience.

PMP certification preferred. Continuously looking for opportunities to learn, build skills, and share knowledge with others. Proven experience with a focus on capital projects within the pharmaceutical industry.

Strong understanding of pharmaceutical manufacturing processes and facilities. 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. Preferred Qualifications:

Greenfield and startup experience strongly preferred. Engineering background and experience is a plus. PMP Certification. Job ID: 378