Working under the direction of the Therapeutic Products Program (TPP) Director, the Project Manager coordinates activities and collaborates with GMP Biologics, GMP Cellular Manufacturing, Quality Assurance, Quality Control, the SCCA Transplant Team Coordinators, Process Development, Divisional Lab Managers, Puget Sound Blood Center, SCCA Apheresis staff, other Data Coordinators, and various Principal Investigators. The Project Manager will also coordinate with external customers regarding delivery timelines, document control and data management.
The position reports directly to the Therapeutic Products Director. The Project Manager is responsible for acting as liaison between the FHCRC Principal Investigator Labs, external customers and the various TPP departments. This position requires flexibility in a rapidly changing environment and the ability to interface across a broad range of disciplines.
The main job tasks include:
- Organize regular project team meetings, plan meeting agendas, record and distribute meeting notes. Use technical judgment to identify agenda items/issues that need to be discussed.
- Create and track project timelines.
- Use technical judgment to identify critical path activities and coordinate with responsible parties to ensure deliverables are achieved.
- Use technical judgment to identify/suggest areas where programs can be run more efficiently
- Use technical judgment to recommend how to prioritize competing activities and facilitate buy-off by stakeholders
- Track action items, deliverables, and key decisions with technical understanding
Manage and monitor process development and manufacturing data
- Track and organize process data that is generated in PI Labs, development, and manufacturing that is generated during the course of process transfer and during clinical manufacturing processes.
- Assist in data analysis and the identification of out of trend results
- Coordinate and/or participate in the generation of written reports and summaries
Provide supply chain management support
- Assist TPP departments in the supply chain management of unique raw materials that are used for clinical manufacturing (e.g. growth factors, custom reagents, other high value or difficult to source items)
Support subject matter experts in troubleshooting unexpected development and manufacturing problems as they arise.
- Organize ad hoc meetings and coordinate with key stake holders
- Participate in the organization of data, root-cause analysis, and execution of corrective actions
Assist in the creation and management of process development and GMP manufacturing contracts, budgets and timelines for grants and other projects.
- Collaborate with PI/project sponsors to identify a scope of requested development and manufacturing activities
- In collaboration with the areas performing the work, use technical judgment to create a development or manufacturing work plans and estimate time and expenses
- Track services/expenses where billing occurs; send invoices and receipt; ensure that expenses/revenue is allocated to the appropriate budgets
- Track contract deliverables and timelines.
Prepare technical documents in support of the Therapeutic Products Program
- Prepare PowerPoint slides, posters, or other documents with a level of technical understanding that permits the ability to work with some independence
- Make oral presentations and be able to speak to and defend the content with some degree of technical knowledge
- BS or higher degree in a life sciences, engineering, or equivalent technical experience
- Excellent project integration, leadership, communication and stakeholder management skills
- Experience with scheduling and setting, tracking and managing project budgets.
- 10 or more years previous biotech or clinical experience related to the development and GMP manufacturing of therapeutic products
- Previous technical project management experience responsible for coordinating CMC activities
- Proficient in MS Office products (Access, Word, Power Point, Project, Outlook)
- Excellent communication skills and ability to build a rapport with a variety of technical groups.
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