CMC Project Leader, Vaccines and Immune Therapies (V&I), BioPharmaceutical Development

AstraZeneca•Gaithersburg, MD

About The Position

CMC Project Leader, Vaccines and Immune Therapies (V&I), BioPharmaceutical Development 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 drives 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 Biologics CMC Project Leader collaborates with the V&I (Vaccines and Immune Therapies) Therapeutic area (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. Main Duties & 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 Vaccines and Immune Therapies 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. Additional responsibilities at the Senior Director level will also involve mentoring and career development of Project Leaders and CMC team members, building strong trusted partnerships across the V&I Therapeutic Area 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. Provide vaccine specific and/or infectious disease biologics CMC expertise and direction to CMC Project leaders that will lead vaccine and infectious disease biologics CMC programs and ensure seamless integration with early research as well as transition to commercial manufacturing.

Requirements

Ph.D. in microbiology, molecular biology, biochemistry, chemical engineering, pharmaceutical science 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 Vaccines CMC Development or equivalent (plus considerable industry experience)
Expertise in technical development and project leadership of platforms like VLPs, mRNA, bioconjugates, mAbs, and other biologic modalities.
Experience in end-to-end CMC development of infectious disease biologics including those used as prevention and treatment working closely with both early research as well as commercial manufacturing teams
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.
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

Responsibilities

Co-lead the CMC matrix teams with the CMC PM.
Accountable for planning and delivering Vaccines and Immune Therapies 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.
Evaluate risks in real time to ensure team engagement and mitigation plans are activated as required.
Mentoring and career development of Project Leaders and CMC team members.
Building strong trusted partnerships across the V&I Therapeutic Area and Senior Leadership Teams.
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.
Provide vaccine specific and/or infectious disease biologics CMC expertise and direction to CMC Project leaders that will lead vaccine and infectious disease biologics CMC programs and ensure seamless integration with early research as well as transition to commercial manufacturing.