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Project Manager, Device Project Management, AstraZeneca, Gaithersburg, USA

Project Manager, Device Project Management, AstraZeneca, Gaithersburg, USA
Posted on: Nov.22.2022

Project Manager, Device Project Management, AstraZeneca, Gaithersburg, USA

About Us

AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.

Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

About AstraZeneca in Gaithersburg, MD:

Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world.  This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.

Summary of the group:

The Device Project Management Group drives the AstraZeneca Device project delivery supporting clinical studies and commercial launch. Device Project managers plan, coordinate, and deliver Device activities in line with project requirements and timelines; plan and monitor resources and expenses for product development; and perform strategic planning for platform and novel processes. The group interfaces globally with the CMC team, Drug Product team, Operations, Quality, Regulatory, and all development functions.
The Project Manager, Device Project Management works collaboratively with the Device Team Lead  to ensure project goals and milestones are achieved, as well as the CMC PM to ensure that Device activities align with the overall CMC Plans.  You must effectively collaborate with staff and leaders in Device Development, Quality, Regulatory Affairs, Drug Development, Process Engineering and across other areas of Biologics Product Development and AstraZeneca. Strong communication skills are required including succinct and effective presentation of technical and non-technical materials during meetings with company Senior Management / Leaders, health authorities, audits and other internal and external stakeholders.  This role has a high job complexity and the successful candidate must have a high level of independence to meet requirements outlined below with minimal to no supervision.

Main Duties & Responsibilities:

Responsible for ensuring Device projects are delivered to time, quality, budget, project standards, company quality standards, and align with AstraZeneca’s strategy
Acts as a source of knowledge in area of expertise associated with defining, communicating and implementing device project management strategy
Acts as a source of knowledge in area of expertise associated with interpreting and applying Design Controls.  Facilitates the planning, execution, and approval of Design Control Deliverables
Develops and maintains processes, tools, and technology required to effectively manage a portfolio of projects
Manages projects to ensure plans are optimal and meet overall strategic goals aligned with clinical and commercial development plans
Introduces new ways of managing and planning projects through use of available systems and resources
Leads and implements strategic initiatives related to Device Project Management and Combination Product Development
Education & Experience Requirements:
Bachelor's, Master's, PhD in a relevant technical discipline such as Biomedical, Mechanical, Engineering, or equivalent industry experience such as Device Regulatory, Device Quality, or Process Engineering
Relevant training (PMP or equivalent) or experience in project management required.
Project Manager: 1 to 3 years of Project Leadership or Management experience (Medical Device or Combination Product Development) is required
Successful candidate must have experience in planning and managing the cross functional aspects of Device product development.
The candidate will have demonstrated knowledge and application of Project Management tools
This position requires a high level of commitment, flexibility and independence with strong skills for planning, coordination, teamwork, communication and interpersonal relations.

Required Skills:

Requires an ability to assess scientific data
Comfortable with ambiguity
Must be professional, dedicated, and detail-orientated
Excellent oral and written communication, interpersonal, analytical, and computer skills.
Effective problem solving and analytical skills to tackle and manage a broad range of issues and projects and deliver innovative solutions
Highly organized and able to work independently on multiple tasks in a fast-paced environment

Desired Skills:

Advanced degree within field
Professional Project Management certification
Portfolio management experience
Experience managing departmental budget and resource planning

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

So, what’s next!

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
Where can I find out more?
Check out our landing page for more information on our BPD group  https://careers.astrazeneca.com/bpd
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
Date Posted
21-Nov-2022
Closing Date
AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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