Associate Director, Business Planning & Project

About the Company

Responsibilities

• ● Meet project goals.
• ● Oversee and brief staff on how to manage projects.
• ● Anticipate customers' needs and find ways to provide solutions for them.
• ● Ensure operational plans are tracked and highlight progress towards main milestones to ensure agreement of task dependencies associated with internal and external manufacturing activities.
• ● 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 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-functional teamwork to become a high-performing team.

Requirements

• ● 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.
• ● 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.

Benefits

• ● The annual base pay for this position ranges from 127,211.20 - 190,816.80.