Head, CMC Project Leadership and Vaccine Strategy, Vaccines and Immune Therapies (V&I)

Gaithersburg, MD

Employer:	AstraZeneca
Job Type:	Full Time
Description
Position: Head, CMC Project Leadership and Vaccine Strategy, Vaccines and Immune Therapies (V&I) Location: Gaithersburg, MD/US Competitive Salary & Benefits 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. Summary of the group The Biologics CMC Project Leadership Group is a new group being formed 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; and perform strategic planning for platform and novel processes. The group interfaces globally with research, Clinical, Operations, Regulatory, and all development functions. The Head, CMC Project Leadership and Vaccine Strategy, V&I will work collaboratively with the V&I Therapeutic Area in AstraZeneca, the Biopharmaceutical Development functions, and CMC Teams to ensure that goals and milestones are achieved. The role provides CMC and leadership expertise to CMC Teams to ensure efficient planning and delivery of company strategy. This role leverages CMC Leadership experience to interface with internal and external partners. This role has a high job complexity, and the successful candidate must have a proven track record of leadership, project delivery, and stakeholder management. Additionally, this role will bring expertise and experience in development of vaccines to ensure seamless integration of Vaccine CMC strategy into overall product development strategy. Main Duties & Responsibilities: Accountable for V&I vaccines and biologics portfolio of CMC programs and their CMC strategies from research transition through to first wave of submissions and CMC launch support. Provide vaccine specific CMC expertise and direction to CMC Project leaders that will lead vaccine CMC programs and ensure seamless integration with early research as well as transition to commercial manufacturing. Provide insight into key trends, drivers, milestones, supply/demand for V&I Vaccines and Biologics CMC project portfolio and continue to refine and implement risk-based CMC strategies with functional leaders. Design group structure and future growth and lead a team of full-time CMC project leads, as well as define matrix responsibilities for functional CMC project leads. Define, build, and maintain strong trusted partnerships across V&I departments, and Senior Leadership teams. Closely align Biopharmaceutical Development (BPD) and Operations interests to enable smooth transitions from development to commercial and lifecycle management activities requiring BPD support. Support and align with BPD cross-functional interests to develop and accomplish strategic goals. Develop and implement a robust training system for CMC project leads and maintain CMC guidance for BPD. Recommend project lead assignments in coordination with BPD governance. Collaborate with BPD functions to facilitate development and implementation of new technologies. Member of BPD leadership team, BPD governance and other governance bodies for therapeutic areas and operations. Manage needs and prioritization across the R&D unit and support TA Liaison responsibility to negotiate and resolve any differences between project constraints and TA demand. Influence and negotiate with senior leaders to bridge TA and BPD requirements and strategies. Plan and coordinate with TAs on portfolio delivery, budget projection and FTE needs. Communicate TA strategy and prioritization to BPD stakeholders. Education & Experience Requirements Extensive experience working in Vaccines CMC Development or equivalent (plus considerable industry experience) Expertise in technical development and project leadership of vaccines developed from platforms like VLPs, mRNA, bioconjugates Experience in end-to-end CMC development of vaccines working closely with both early research as well as commercial manufacturing teams Mastery of Scientific Project Leadership with an ability to lead cross functional working groups and teams Proven leadership abilities and experience promoting, motivating, and empowering others to accomplish individual, team, and organizational objectives Strong track record of CMC Biologics project delivery and successful delivery to market Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment Experience leading a matrix development team and working in a global environment. Expert reputation within the business and industry Extensive knowledge of the latest technical and regulatory expectations Strong track record with marketing applications, response to questions, and preapproval inspection readiness Experience leading large, global, late-stage CMC development Familiarity with the latest research, technology, and trends Required Skills PHD or equivalent Ability to influence strategically and persuade tactfully, to obtain desired outcomes while maintaining effective, positive, organizational relationships Operational expertise in risk management and contingency planning Effective problem solving and conflict resolution skills Ability to assess and make decisions based on scientific data Comfortable with ambiguity Excellent oral and written communication, interpersonal, and analytical skills Effective problem solving and analytical skills to tackle and manage a broad range of issues and projects and deliver innovative solutions 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! Please apply by submitting your CV by COB 13th September 2024. 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 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.

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Head, CMC Project Leadership and Vaccine Strategy, Vaccines and Immune Therapies (V&I)

Gaithersburg, MD

Description