PROJECT MANAGER II - CDMO/SPECIAL PROJECTS
Job Summary:
The Project Manager will lead cross-functional teams in preparing project timelines, scope, deliverables, communication plans and budgets to ensure milestones are met and projects are completed on time. Projects will focus mainly on CDMO projects, but may include other post-submission, tech transfers, and special projects.The 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.In this role, the PM will serve as the primary customer contact/advocate and escalate any matters as required to the Director of PM/AM.
Responsibilities:
- Lead and manage multiple complex projects simultaneously, including oversight of the project scope, critical path, timeline and financial milestones
- Develop, manage and communicate project plans and other company tracking tools to internal and external teams.
- Work with the appropriate department head to develop project budgets, scope of work and risk assessments as part of the lifecycle management process
- Communicate project objectives, deliverables, timelines and tasks to team members, both internal and external teams.
- Primary communication with customers on all CDMO project related activities.
- Coordination of customer meetings, visits when onsite
- Assist the department in overall coverage, as needed
- Work with internal and external project stakeholders to manage current projects and initiate new projects; including setting timelines, coordinating meetings, identifying and helping to resolve obstacles, and escalate issues when necessary to support resource allocation and on-time project completion
- For internal projects, manage the ANDA deficiency tracking system and gap analysis program to ensure that action items are completed on time to support timely approvals for post-submission activities
- Demonstrate leadership qualities while facilitating team meetings to ensure the agenda is followed, coordinate follow-up on action items
Education/Qualifications:
- Bachelor’s Degree Required
- Minimum of 2 years of project management experience in the regulatory, scientific or pharmaceutical industry required.
- PMP certification preferred
- Working knowledge of product development and related industry guidelines, such as ICH and GMP
- Understanding of FDA regulatory development and submission processes
- Proficiency with MS Office Programs, including MS Project
- 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
- Excellent customer service and communication skills
- Leadership, negotiation, presentation and facilitation skills
- Ability to work with minimal supervision to meet required timelines
- 5% travel as needed
