Associate Director, Business Planning and Project Management

Position Summary

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 Clinical Manufacturing Site Head.

Responsibilities

Following skills are necessary to perform the core tasks associated with this job:

• 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 resourcing 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, 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, 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, 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 discipline (such as chemistry, pharmaceutical sciences, biochemistry, molecular biology, chemical engineering or equivalent.)
• Five (5) plus years of experience in project management in pharmaceutical/biotechnology industry with first-hand understanding of 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, 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 including medical, prescription drug, dental, and vision coverage.