Associate Director/director, Cmc Project Management

6 months ago


Cambridge, United Kingdom AstraZeneca Full time

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 builds 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 innovative 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.

**Associate Director -**

Main Duties & Responsibilities**:

- Responsible for ensuring CMC 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 project management strategy
- Develops and maintains processes, tools, and technology required to effectively handle a portfolio of projects
- Manages projects to ensure plans are optimal and meet overall strategic goals aligned with clinical development plans
- Introduces new ways of leading and planning projects through use of available systems and resources
- Leads and implements strategic initiatives related to CMC Project Management and BioPharmaceuticals Development

**Director -**

Main Duties & Responsibilities**:

- Leads translation of drug development and clinical development strategies into CMC project plans and deliverables (timeline, budget, resource plan, risk assessment, and achievements).
- Monitors risks in real time to ensure team engagement and mitigation plans are activated as required. Anticipates and resolves challenges affecting goals and objectives
- Partners with the CMC Team Leader to drive the CMC team to meet goals and challenges as required
- Facilitates communications involving team members and/or external partners.
- Leads and implements pivotal initiatives related to CMC Project Management and BioPharmaceuticals Development
- Introduces new/improved ways of managing and planning projects through use of available systems and resources

**Education & Experience Requirements**:

- Bachelor's, Master's, PhD or equivalent industry experience in a relevant technical discipline such as Biochemistry, Molecular Biology, Microbiology, Genetics, Immunology or Chemical Engineering.
- Relevant training (PMP or equivalent) or experience in project management required.
- Project Management experience (preferably in CMC) is required.
- This position requires a high level of commitment, flexibility and independence with strong skills for planning, coordination, collaboration, 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 take on 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
- Business Strategy and Portfolio operational experience
- Combined experience of Project Management in a CMC or Process Development function

**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



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