Tech Transfer Project Manager

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. 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 below to read a recent article from the New England Journal of Medicine.

https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189

Video Intro to Civica: https://vimeo.com/646267406

Position Responsibilities

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. The role also extends to similar activity in launching internal products. 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.

Major Accountabilities

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, VA 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 central accountability that all aspects of product launch are coordinated to lead to a successful regulatory approval and commercial go-live.

• 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 Regulatory Affairs.

• 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.

• 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.

• Strong interpersonal skills as interactions will be both internal and external facing.

• Lead multiple cross-functional projects of medium to high complexity.

Relevant Skills / Experiences

• Experience in pharmaceuticals or cGMP environment, with a preference for injectable drug products. Experience in closely related fields such as medical devices or DEA may also be applicable.
• Experience in a broad portfolio of pharmaceutical functional areas relevant to the role. This may includes but is not limited to quality assurance, supplier qualification, laboratory testing, validation, procedures, master batch records, operations, and regulatory affairs.

• 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.
• Relevant IT skills - able to work with Visio, Microsoft Project, PowerPoint, Excel, and/or Oracle Primavera for project management. Skills such as Gantt charts are required.
• Ability to think strategically and tactically (detail-oriented).
• Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment.
• 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.
• Experience with the preparation of reports and/or presentations/ communications via presentation tools such as PowerPoint, project dashboards and written reports.

Education (minimum/desirable)

• Bachelor's degree from an accredited college/university (a degree in relevant sciences, engineering or medically related field is preferred).
• Advanced degree or certification, such as an MBA, is desired.
• Project Management Professional (PMP) certification is a plus.

Relevant Skills / Experiences

• Minimum 3 years of 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 pharmaceuticals or cGMP environment, with a preference for injectable drug products. Experience in closely related fields such as medical devices or DEA may also be applicable
• Experience in a broad portfolio of pharmaceutical functional areas relevant to the role. This may include but is not limited to quality assurance, supplier qualification, laboratory testing, validation, procedures, master batch records, operations, and regulatory affairs
• Relevant IT skills - able to work with Visio, Microsoft Project, PowerPoint, Excel, and/or Oracle Primavera for project management Skills such as Gantt charts are required
• Ability to think strategically and tactically (detail-oriented)
• Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment
• 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
• Experience with the preparation of reports and/or presentations/ communications via presentation tools such as PowerPoint, project dashboards and written reports

Education (minimum/desirable)

• Bachelor's degree from an accredited college/university (a degree in relevant sciences, engineering, or medically related field is preferred)
• An advanced degree or certification, such as an MBA, is desired
• Project Management Professional (PMP) certification is a plus

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