Manager/Senior Manager, Project Management – Combination Products @ AbbVie
The Manager/Senior Manager will be accountable to the Program Manager Director for delivering on the strategy, plans, and budget defined for the project portfolio.
- Leadership of a portfolio of drug delivery system product development projects. Portfolio volume will be commensurate with job level.
- Tactical and strategic management of external device partners including acting as a key interface, managing the project governance process and forward-looking evaluation of potential partners
- Device financial management including budgeting, forecasting and long-range planning of delivery development expenses
- Representing the R&D organization to cross-functional leadership through effective and timely communication
- Ensuring effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions
- Driving continuous improvement on Program/project management processes and tools
- Direct management of project managers with responsibility for device/device constituent development projects
- Required: Bachelor’s Degree in Engineering or related technical field
- Preferred: Masters in Engineering or Business Administration
- Certification: Project Management Professional (PMP) Certification preferred, but not required
- Manager minimally requires 8+ years of experience in the combination product or medical device industry with proven experience in developing and launching combination products; broad experience in design controls, human factors studies, design verification/validation and usability studies.
- Senior Manager minimally requires 10+ years of experience in the combination product or medical device industry with proven experience in developing and launching combination products; broad experience in design controls, human factors studies, design verification/validation and usability studies.
- Leadership of technical professionals; proven effective leader to cross-functional teams with focus on commercialization, equipment selection, build and qualification of delivery systems
- On-body delivery systems, auto-injectors, pumps and pre-filled syringes and smart packaging design experience required.
- Skilled in the initiation, selection, coordination and management of projects and have the ability to solve unique problems.
- Requires an in-depth understanding of the pharmaceutical product development cycle.
- Design history file, project management and product development experience is essential.
- Conflict resolution skills including persuasive management techniques required. Effective communication and people management capability.
- Ensure timely execution of incoming reportable device combination product events to comply with global regulations.
- Must have working understanding and application of GMP principles, concepts, practices and standards as well as relevant related regulatory requirements for commercialization in diverse global markets (United States, Europe, Asia, Latin America).
- Up to 20% travel may be required to effectively manage communication between multiple Abbvie sites and third-party suppliers
Experience Level: Senior
Work From: Onsite
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