Are you passionate about science? Do you want 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. We are entrepreneurial, think big and work 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.
Our Gaithersburg, Maryland facility creates life-changing medicines for people globally. This campus employs more than 3,500 authorities 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 pioneering technology and lab spaces, all designed to inspire collaboration and cross-functional science.
The Biologics CMC Project Leadership Group is a new function established to drive the AstraZeneca Biologics pipeline projects from early research to launch. Biologics CMC Project Leaders plan, coordinate, and deliver CMC activities in line with project requirements and company prioritization. The group interfaces globally with Research, Clinical, Operations, Regulatory, and all development functions.
The Biologics CMC Project Leader collaborates with the Therapeutic areas (TA) in AstraZeneca, the BioPharmaceutical Development (BPD) functions, and leads CMC Project Teams to ensure that goals and due dates are achieved. The role provides technical expertise and leadership to CMC Teams to ensure efficient planning and delivery of company strategy, leveraging your CMC Leadership experience to work with internal and external partners. The job has high complexity, and the successful candidate must have a consistent record of leadership, project delivery, and partner management.
Responsibilities
As a Director Biologics CMC Project Leadership, you will co-lead the CMC matrix teams with the CMC PM. You will be accountable for planning and delivering Oncology or Biopharma Biologics CMC programs and their CMC strategies transitioned from Research through to first wave of marketing application submissions and CMC launch support, ensuring project plans and development milestones are completed to meet agreed project timelines. You will also evaluate risks in real time to ensure team engagement and mitigation plans are activated as required.
The Senior Director will also be responsible for the mentoring and career development of Project Leaders and CMC team members, building strong trusted partnerships across AZ therapy areas and Senior Leadership Teams, and influencing Senior Leaders to bridge TA and CMC requirements for portfolio projects. Align and implement BPD and Operations Global CMC program hand-offs to enable smooth transitions from development to commercial and lifecycle management activities requiring BPD support. Communicate TA strategy and prioritization to BPD partners. Lead and coordinate portfolio delivery, budget, and FTE needs, with TA Portfolio Leads.
Essential Experience:
Director:
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