Provide project coordination support for project teams in the in support of the INTERCEPT Blood System.
- Responsible for directing, organizing and controlling project activities, under the direction of a Project Manager (PM).
- Assist the PM in the drafting and issuance of project proposals, RFP’s, tenders, budgets, cash flows and preliminary schedules.
- Manage the contract manufacturers, contract laboratories, and supplier base for Cerus development projects.
- Manage the review and approval of contracts and work orders with contractors.
- Follow up on work orders, verify delivery of products or services, and maintain necessary records.
- Track and monitor the progress and quality of work being performed by project team members.
- Assist the PM in the creation and archival of various project artifacts, including the Design History File.
- Assist the PM in facilitating team meetings and other key project-related meetings; prepare agendas, meeting minutes, and action items.
- Communicate outcomes from team meetings and supplier meetings to team and PM via monthly reports, timelines and project reviews.
- Requires a Bachelor’s in a scientific or technical discipline with a minimum of 3 years experience in the healthcare, biotechnology or pharmaceutical industry.
- Experience with contract manufacturing, contract negotiation, planning, or outsourcing experience in the pharmaceutical industry.
- Passion for business analysis and utilizing quantitative metrics to guide successful business outcomes.
- Strong quality orientation with demonstrated attention to detail.
- Experience using project scheduling and control tools to monitor projects plans, work hours, budgets and expenditures.
- Strong working knowledge of MS Office and project scheduling tools such as MS Project. Experience with Earned Value Management systems is preferred.
- Works well in a collaborative team environment and communicates effectively with all levels of the organization.
- Ability to identify and independently manage priorities, task assignments, and dependencies within a project.
- Understanding of medical device regulations (EU Medical Device Directives, US Quality System Regulations), design control (e.g. ISO 13485), and risk management (e.g., ISO 14971).
- Excellent written and verbal communication skills.
- Experience using Agile Project Management Methodologies preferred.
- CAPM certification preferred.