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.

The Associate Director Business Planning and Project Management manages 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 Santa Monica, CA, and reports to the Clinical Manufacturing Site Head.

What you will do:

Communication - to create detailed reports and plans

Meet project goals

Leadership - to oversee and brief staff on how to manage projects

Customer service - to know what 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 milestones.

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 resource allocation for site operations and project portfolio.

Coordinate site teams, including scheduling meetings, and organizing ad hoc working groups. sending out agendas, writing and distributing meeting summaries, managing 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 excellence, and cross- to become a high-performing team.

Required Abilities

Pre-IND through clinical manufacturing experience or site operations is ideal.

Proficiency in financial modeling, and data analysis tools.

Relevant training (PMP or equivalent).

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 Microsoft Project 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.

Education and Experience

Bachelor of Arts or Sciences degree with 10+ years of experience OR Masters or MBA with 8+ years of experience.

Industry experience in an operations or relevant technical field (such as chemistry, pharmaceutical sciences, biochemistry, molecular biology, chemical engineering, or equivalent.)

Five (5) plus years of experience in project management in the pharmaceutical/biotechnology industry with a first-hand understanding of the drug development process, with prior experience in a CMC leadership role.

The anticipated salary range for candidates who will work in Santa Monica, CA is $131,727 to $160,999. The final salary offered to a successful you are dependent on several factors that may include but are not limited to the type and length of experience in the job type and length of experience within the industry, and education.

When we put unexpected teams in the same room, we fuel 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.

Benefits

Short-term incentive bonus opportunity

Equity-based long-term incentive program

401(k) plan

Paid vacation and holidays; paid leaves

Health benefits include medical, prescription drug, dental, and vision coverage.

Date Posted

22-Sep-2024

Closing Date

06-Oct-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.