Description

The Senior Project Manager is responsible for leading and coordinating multiple concurrent projects within a pharmaceutical manufacturing environment. This role partners with cross-functional teams across multiple departments to plan, execute and deliver projects timely that support business objectives. Projects will range from early product development through commercial launch; product transfers, special projects, and CDMO projects through launch. The Senior Project Manager coordinates the resources required for successful project completion, identifies and removes roadblocks, and maintains project tracking tools to provide up-to-date project status as required.

Leads and manages multiple complex projects simultaneously, including oversight of project scopes, schedules, budgets while identifying proactively identifying and removing roadblocks.
Develops, manages and communicates project plans and other company tracking tools

Communicates project objectives, deliverables, timelines and tasks to cross functional team members

Work with project stakeholders to initiate new projects, set timelines, coordinate meetings, identify and help to resolve obstacles, and elevate issues when necessary to support resource allocation and on-time project completion
For unapproved products, manage the deficiency tracking system and gap analysis program to ensure that action items are completed on time to support timely approvals
Demonstrate leadership qualities while facilitating team meetings to ensure the agenda is followed, coordinate follow-up on action items
If applicable, proactively track, monitor and communicate contract milestones, obligations and any financial payments to project team leaders and management.

Proactively identify project risks and assist in developing mitigation strategies. Communicate both positive and negative impact to the project.

If applicable, support Director in partner collaborations and attend business review meetings.

Requirements

Experience

Bachelor’s degree in scientific, engineering, business, project management or related discipline.
Minimum of 10 years of project management, preferably within pharmaceutical manufacturing.
Experience coordinating projects involving multiple functional departments and organizational levels.
PMP Certification preferred but not required

Skills

Understanding of FDA regulatory development and submission processes
Proficiency with MS Office Programs, including MS Project and MS Teams/Planner
Proven ability to manage multiple, multi-faceted projects and deliver results
Experience working with multidisciplinary groups (internal & external) and ability to work in and communicate across all levels of the organization
Leadership, negotiation, presentation and facilitation skills

Ability to work with minimal supervision to meet required timelines

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