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Director/Senior Director Biologics CMC Project Leadership

Location Gaithersburg, Maryland, United States Job ID R-198661 Date posted 04/06/2024

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:

  • Ph.D. in microbiology, molecular biology, biochemistry, or a related subject area with 7+ years of proven experience, or a Masters with 10+ years of experience or a B.S. with 13+ years of experience.
  • Extensive experience working in CMC Development or equivalent.
  • Demonstrated Scientific Project Leadership with an ability to lead cross-functional matrix teams.
  • Consistent track record of CMC Biologics project delivery.
  • Demonstrated ability to set and lead priorities, resources, performance targets and project initiatives in a global and regional environment.

Senior Director:

  • Ph.D. in microbiology, molecular biology, biochemistry, or a related subject area with 10 + years of experience, or a Masters with 13+ years of experience or a B.S. with 16+ years of experience.
  • Extensive knowledge of the latest technical and regulatory expectations.
  • Experience with marketing applications, responding to questions, and pre-approval inspection readiness.

Required Skills:

  • Ability to influence strategically and persuade tactfully, to obtain desired outcomes while maintaining effective, positive, organizational relationships.
  • Expertise in risk management, contingency planning and delivering innovative solutions.
  • Effective problem solving and conflict resolution skills.
  • Ability to assess and make decisions based on scientific data.
  • Exceptional presentation skills and ability to speak in front of large groups.
  • Effectively manage ambiguity and complexity.
  • Excellent oral and written communication, interpersonal, and analytical skills.

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and high-reaching world.

Why AstraZeneca?

At AstraZeneca, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Are you ready to embrace new and varied opportunities to develop and learn? Are you ready to build a long-term meaningful career? Are you ready to push the boundaries of science to deliver life-changing medicines? If yes, then apply now!

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.

10000725 G PRSP

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.