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.

• 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.

• 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 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.

• Ph.D. in microbiology, molecular biology, biochemistry, chemical engineering, pharmaceutical science 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 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 commercial manufacturing teams.

• Extensive knowledge of the latest technical and regulatory expectations as it relates to Oncology biologics CMC.

• Experience with marketing applications, responding to questions, and pre‑approval inspection readiness.

• Ph.D. 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.

The annual base pay for this position ranges from $ - $ USD. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards…