Associate Director, Business Planning and Project Management

Position Summary

The Associate Director Business Planning and Project Management is responsible for managing the clinical site project portfolio and lifecycle and related projects for Neogene's portfolio of T-cell therapy programs. This position integrates the inputs across each of the Tech Ops functions to form and operationalize the project portfolio and business planning objectives. This position is based in Santa Monica, CA and reports to Clinical Manufacturing Site Head.

Essential Functions and Responsibilities

• In conjunction with critical thinking, the following skills are essential to perform the core tasks associated with this job:
• Communication - to create detailed reports and plans
• Problem-solving - to keep projects on track and meet project goals
• Leadership - to supervise and brief staff on how to carry out projects
• Organization - to manage multiple projects at once
• Customer service - to know what customers need and find ways to provide it for them through focused solutions
• Ensure operational plans are proactively tracked and highlight progress towards key milestones to ensure alignment 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 cross-functional working plans and timelines, help teams proactively identify and mitigate risks, and ensure sufficient resourcing to achieve program goals.
• Responsible for the maintenance of requisite project documentation including detailed timelines, resource allocation and task prioritization to ensure delivery of the overall site operating plan and milestones.
• Utilize processes and tools including scenario planning, gap analysis, decision making, escalation process and, risk management in collaboration with team members, program teams and functional leads.
• Create, maintain, and articulate for various 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 cross functional teams, including scheduling and facilitating 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 alignment with the CMC development plan.
• Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team.

Required Skills/Abilities

• Pre-IND through clinical manufacturing experience or site operations is ideal.
• Proficiency in financial modeling, data analysis, and reporting tools.
• Relevant training (PMP or equivalent) is a plus.
• Knowledge of GxP, Quality Systems, and FDA regulations.
• Good understanding of CMC development and manufacturing is desired.
• Excellent oral and written communication, interpersonal, analytical and computer skills, leadership and collaboration skills.
• Hands-on experience working in a CMC function.
• Solid knowledge of Microsoft Project and other project management tools.
• Demonstrated strategic thinking capabilities with forward looking perspective.
• Leads without direct reporting responsibility by setting clear vision, respecting value of subject matter expertise, and empowering cross-functional team members to execute.
• Solid understanding of 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.)
• A minimum of 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 $160,000 to $186,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc.

At Neogene we celebrate the diversity of our employees and our leadership. Neogene is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.