- 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
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Senior Project Manager - Petersburg, United States - Civica Rx
Description
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. )
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
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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:
