Tech Transfer Project Manager
Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration’s shortage list. Manufacturing challenges and predatory pricing are both the cause and result.
Who suffers most? Patients.
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. Led by an experienced team of health care and pharmaceutical industry leaders.
Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent 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 is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”
Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs.
To find out more about how Civica’s innovative model is directly impacting patient care, click here to read a recent article from the New England Journal of Medicine.
Intro to Civica
The Tech Transfer Project Manager will be responsible to develop and maintain product transfer projects and related project team activities in all capacities and serve as the primary contact for both internal and external customers. Working closely with site functional leaders (R&D, QA, Operations and Engineering) this role will lead product transfer activities, coordinate with critical stakeholders, and serve as a liaison to support new initiatives and tech transfer proposals. Serves as project leader for multiple, complex projects related to specified needs and ensure successful product transfers and portfolio growth.
We are seeking a highly motivated Project Manager who is interested in joining our fast-paced, dynamic start-up environment. In this dynamic role you will, provide a strategic dimension to Civica’s tech transfer process and portfolio development and be responsible for responsible for leading new product introduction activities into the Petersburg facility. You must have a willingness to perform "hands-on" work in a dynamic, team-oriented work setting. Incumbent provides technical expertise on Construction, Start-up and Compliance standards and processes to team members; and provides input on schedule strategy to key business leaders.
- Responsible for leading new product introduction activities for new programs' tech transferring into the Petersburg facility.
- Provide project strategic direction of external manufacturing technical transfer and new product introduction activities coordinating execution of cross-functional workstreams from Quality, Process Development, Contracts, Supply Chain, Analytical Sciences and Global Strategic Sourcing.
- Strong interpersonal skills as interactions will be both internal and external facing.
- Lead multiple cross-functional projects of medium to high complexity.
- Build and maintain project plans and team assignments using project planning tools, estimating project cost and adhering to budget, directing and supervising work efforts on daily basis, identifying resource needs, performing project reviews, and advancing functional, quality, timeline and cost issues appropriately.
- Utilize project management processes, software and methodologies to ensure projects are delivered on time, within budget, adhere to high quality standards and meet customer expectations.
- Handle communication with all areas of the enterprise that impact scope, budget, risk and resources of the work being managed and provide project updates and reporting to executive leadership and internal partners.
- Lead continuous improvement projects that deliver measurable gain in quality, efficiency and alignment within Civica priorities. Apply the knowledge, skills, tools of project management and operational perfection to ensure efficient execution of projects and continuous improvement initiatives.
- Establish full project plans, including timeline, critical path assessment, risk assessment, contingency planning, mitigation planning, communication planning, contact listing, and confirm scope capture during planning phase of a project.
- Controls and monitors project progress to ensure that milestones are accomplished on time and communicated as needed.
- Evaluates and adds details to project plan initiated during the proposal in conjunction with all participating departments for confirmation at the initiation of the project. Any changes or additions to the schedule will be first verified against the master schedule and then agreed upon with the team.
- Work closely with site Operations, Validation and Quality management to manage and prioritize the project schedule as it relates to deliverables and deadlines. Candidate with construction, start-up and/or commissioning, qualification, and validation experiences preferred.
Key Performance Indicators
- Bachelor's degree from an accredited college/university (a degree in life sciences, engineering or medically related field is preferred), Project Management Professional (PMP) certification is a plus.
- Minimum 3 years project management experience with relevant experience in biotechnology, life sciences, pharmaceutical or medically related field. Recent college graduates will be considered if they possess strong technical capabilities and an ability to articulate a relative project management mindset.
- Experience in working in a cGMP environment, with FDA & DEA experience is preferred.
- Demonstrated experience in complex strategic planning, project execution, and resource management desirable.
- Experience in successfully coordinating across several complex functions to ensure comprehensive and consistent planning.
- Proficiency in project management principles, practices, and tools such as MS Project (Gantt charts) is required.
- Experience with the preparation of reports and/or presentations/communications via presentation tools such as PowerPoint, project dashboards and written reports.
- A minimum of a bachelor’s degree is required. Advanced degree or certification, such as an MBA, PMP, is desired.
- Relevant IT skills (able to work with Visio, Microsoft Project, PowerPoint and Excel).
- Ability to think strategically and tactically (detail-oriented).
- Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment.