Associate Project Manager/Project Manager CMC-BPD
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 CMC Project Management Group drives the AstraZeneca Biologics project delivery from early research to launch. CMC Project managers plan, coordinate, and deliver CMC activities in line with project requirements and timelines; plan and monitor resources and expenses for product development and clinical manufacture; and perform strategic planning for platform and novel processes. The group interfaces globally with early research, Operations, Regulatory, and all development functions.
Main Duties & Responsibilities:
- Provides project management expertise and application of key project management tools to support the design and execution of project plans and enhance project delivery and information dissemination to the business
- Manages BPD activities, project budgets, expenses and resources for specified projects, interfacing with relevant functional groups, and with external suppliers as necessary, to plan and coordinate the timely execution of CMC activities and contingencies
- Leads and facilitates CMC Team meetings and is responsible for project logistics and production and maintenance of requisite project documentation.
- Interfaces internally and externally as required in evaluation of clinical and nonclinical material demand and to provide appropriate planning, coordination and communication to enable supply of materials and information of the required quality standard.
- Collaborates with BPD functional representatives, harnessing creativity within cross-functional project teams to develop risk mitigation and contingency scenarios for projects
- Communicates effectively with BPD, GPPM (Global Project & Portfolio Management), and with all interfacing functions and relevant governance bodies as required, to align CMC activities with the project strategy, including any necessary changes to the CMC deliverables, and ensure Governance, GPT (Global Product Team) and BPD Leadership Team support.
Education & Experience Requirements:
- Minimum of a Bachelors degree in a relevant technical discipline such as Biochemistry, Molecular Biology, Microbiology, Genetics, Immunology or Chemical Engineering. Master's, or PhD a plus.
- For Associate Project Manager – 2+ years of experience in core CMC functions such as: cell culture, PD, assay, method development, or formulation development
- For Project Manager – 5+ years of experience in core CMC functions such as: cell culture, PD, assay, method development, or formulation development
- Understanding of biologics CMC development and manufacturing and effective working knowledge of the technical disciplines within the CMC team
- Knowledge and application of Project Management tools
- High level of independence with strong interpersonal, collaboration, planning and communications skills
- Excellent oral and written communication, analytical skills, organizational and problem solving skills
- Comfortable with ambiguity and fast pace
- Professional certification or project management training (PMP or equivalent)
- 4+ years industry experience
- 2+ years of Project Management experience (preferably in CMC).
- Experience in planning and managing the cross functional aspects of biopharmaceutical product development.
- Familiarity with Planisware 5 (Opal) or other project & portfolio management system
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.
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 authorisation and employment eligibility verification requirements.