CMC Project Leader, Oncology, BioPharmaceutical Development

AstraZeneca • Gaithersburg, MD

2d

About The Position

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.

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 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.
• 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

Nice To Haves

• 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.

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.

Benefits

• Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree