The Director CMCi (Chemistry, Manufacturing and Controls Integration) Project Management group is responsible for the project management group supporting Process Development activities. The project managers in this group are responsible for integrating, developing and maintaining project schedules for Amgen pipeline and commercial portfolios.
The Director of CMCi will partner with Process Development (PD) functional leaders to develop and identify key activities, interdependencies and deliverables for molecules advancing through development portals and will ensure cross functional alignment and accountability. Additionally, the Director will partner with Global Operations Planning (GOP) to ensure alignment of timelines and expectations with Contract Book deliverables for Product Development Teams (PDTs). This team will provide communication regarding team formation and membership, as well as communication to PD senior leadership regarding conflicts and prioritization challenges.
- Develop and ensure project reporting including appropriate risk analysis.
- Facilitate and incorporate lessons learned, best practices, etc.
- Assist PD in driving decision making using DAI principles.
- Ensure timely and relevant collaboration.
- Partner with Business Analysis and Performance to ensure accurate forecasting and representation of work in PD.
- Participate in the logistics of Drug Substance Technical Review (DSTR) and Drug Product Technical Review (DPTR) meetings as well as in functional and cross functional management reviews.
- Support Business Process improvements, including alignment with CMC Commercialization Future State, IS4PD efforts including Product Lifecycle Management (PLM).
- Critical thinking and problem-solving skills
- 10+ years of experience in the Pharmaceutical, Biotechnology or other Healthcare-related field, direct Chemistry, Manufacturing, and Controls (CMC) experience
- Deep knowledge of Project Management tools, and practices. Experience with MS Project, Excel and SharePoint
- Ability to foster collaboration and work effectively with cross-functional leaders and teams
- Strong interpersonal and communication skills with the ability to effectively interface across all levels of the organization
Qualification & Experience:
- 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Bachelor’s degree and 10 years of Project Management experience
- Master’s degree and 8 years of Project Management experience
- Doctorate degree and 4 years of Project Management experience
Vacancy Type: Full Time
Job Location: Thousand Oaks, CA, US
Application Deadline: N/A