At AstraZeneca's Oncology R&D division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs.

Lead the clinical site project portfolio and lifecycle and related projects for Neogene's portfolio of T-cell therapy programs. You will integrate the inputs across each of the Tech Ops functions to form the project portfolio and business planning goals. This position is based in Gaithersburg, MD and reports to the Clinical Manufacturing Site Head.

What you will do:

• Meet project goals
• Oversee and brief staff on how to manage projects
• Anticipate customers need and find ways to provide it for them through focused solutions
• Ensure operational plans are tracked and highlight progress towards main milestones to ensure agreement of task dependencies associated with internal and external manufacturing activities. Responsible for efforts associated with process development, analytical development, manufacturing, quality, and supply chain.
• Contribute to working plans and timelines, help teams find and address risks, and ensure resources to achieve program goals.
• Maintain requisite project documentation including detailed timelines, resource allocation, and task prioritization to ensure delivery of the site operating plan and achievements.
• Use tools including scenario planning, gap analysis, escalation process, and, risk management in collaboration with team members, program teams, and functional leads.
• Communicate for multiple audiences detailed project or business plans to ensure clarity of deliverables and timing including identifying drivers for each action item.
• Conduct financial analysis and forecasting to support decision-making and prioritization for site operations and project portfolio.
• Coordinate site teams, including scheduling meetings, and coordinating ad hoc working groups. sending out agendas, writing and distributing meeting summaries, developing team documentation, and tracking goals and action items.
• Work with external and internal technical subject matter experts to track deliverables and action items, and manage agendas, timelines, and agreement on the CMC development plan.
• Promote a culture of collaboration, cooperation, inclusion, execution perfection, and cross- to become a high-performing team.

Required

• BA or BS degree with 8+ years of experience
• Masters or MBA with 6+ years of experience.
• Industry experience in an operations or relevant technical field (such as chemistry, pharmaceutical sciences, biochemistry, molecular biology, chemical engineering, or equivalent.)
• Clinical or commercial manufacturing experience or site operations is ideal.
• Proficiency in financial modeling, and data analysis tools.
• Knowledge of GxP, Quality Systems, and FDA regulations.
• Experience with CMC development and manufacturing.
• Excellent oral and written, leadership and collaboration skills.
• Hands-on experience working in a CMC function.
• Solid knowledge of Smartsheet and other project management tools.
• Lead without direct reporting responsibility by setting clear vision, respecting value of subject matter expertise, and empowering team members to implement.
• Experience with drug development, biologics manufacturing, and global operations.

The annual base pay for this position ranges from $125,056.80 - $187,585.20. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. 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.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Join us in our unique and ambitious world.

Here, courage, curiosity, and collaboration fuel a relentless focus on transforming cancer outcomes, powered by a pipeline that fuses cutting-edge science with advanced technology. You will work in an environment where unexpected teams come together to spark bold ideas, backed by meaningful investment and a clear path from discovery to impact. We value kindness alongside ambition, and we empower leaders at every level to ask sharp questions, take smart risks, and turn data into decisions that help patients sooner.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.