CMC Project Leader, Oncology, BioPharmaceutical Development

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 Oncology Therapeutic area (TA) in AstraZeneca, the BioPharmaceutical Development (BPD) functions, and leads CMC Project Teams to ensure that goals and due dates are achieved. This 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: 

• 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 Oncology 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 Oncology specific biologics CMC expertise and guidance to less experienced Project leaders that will lead Oncology biologics CMC programs and ensure seamless integration with early research as well as transition to commercial manufacturing. 

Education & Experience Requirements, Director 

• 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 Oncology biologics CMC Development or equivalent (plus considerable industry experience) 

• Expertise in technical development and project leadership of platforms like ADCs, immune engagers, radio-conjugates, mAbs, and other biologic modalities.  

• Experience in end-to-end CMC development of Oncology biologics including close collaboration with both early research as well as commerc