CMC Project Manager, Sr

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer with minimal side effects.

An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

Working under the direction of the Director of Alliance Management in the Therapeutic Products Program (TPP), the CMC Project Manager coordinates activities for/among Process Development (PD), GMP Cellular Manufacturing (CPF), GMP Biologics (BPF), Quality Control (QC), and Quality Assurance (QA), Principal Investigators (PIs) and external collaborators regarding timelines, document control, and data management to ensure Products and other project deliverables are provided on-time and within budget.

The Project Manager also partners with Fred Hutch Center IT, Finance and Shared Resources Administration to implement and oversee a budget and expense management system for operational support of PD, CPF, BPF, QC and QA.

The position reports directly to the Director of Alliance Management. The CMC Project Manager is responsible for implementing and maintaining tools in support of the budget making process and data collected from these tools for use in evaluation and improvement of manufacturing operations. The Project Manager is also responsible for acting as a liaison between FHCRC PI labs, external customers and the various TPP departments, as required. This position requires flexibility in a rapidly changing environment, a strong understanding of GMP manufacturing and the ability to interface across a broad range of disciplines.

In addition, this position will work with internal and external clients to translate experimental designs in immunotherapies and cellular therapeutics into FDA Regulated GMP processes for Phase I & II Clinical Trials, transfer processes in preparation for Phase III & Commercialization and provide project management support to the Research Donor program.

Budgeting and expense management:
- Implement a budgeting and expense management system to build robust, dynamic and transparent budgets for TPP projects
- Track project-specific, general facility and GMP-related operational expenses (e.g., labor, supplies, etc.) for PD, CPF, BPF, QC and QA
- Utilize the expense data to improve the budgeting process, expense management system and facility operations

Creation and management of PD and GMP manufacturing contracts and timelines:
- Collaborate with Project Sponsors and/or PIs to scope requested process development and manufacturing activities
- In collaboration with the functional teams performing the work, use technical judgment to assist in developing work plans and creation of project budgets, milestones and deliverables
- Track services/expenses; send invoices and receipts, as required; ensure that expenses/revenue is allocated to the appropriate budgets
- Track contract terms, deliverables, and timelines

Project Management:
- Organize routine and ad hoc meetings, and coordinate with key stake holders
- Participate in the organization of data, root-cause analysis, and execution of corrective actions
- Analyze process work flows to capture both time and cost savings to the benefit of the Center, clients, and affiliates

Support the Therapeutic Products Program:
- Work with a team to draft and submit the CMC section of Investigational New Drug (IND) applications and amendments to INDs
- 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
- Using technical judgment, create and track project timelines
- Identify critical path activities and coordinate with responsible parties to ensure deliverables are achieved
- Identify/suggest areas where programs can be run more efficiently
- Recommend how to prioritize competing activities and facilitate buy-off by stakeholders
- Track action items, deliverables, and key decisions with technical understanding

- BS or higher degree in a life sciences, engineering, or equivalent technical experience
- 5 or more years previous biotech or clinical experience related to GMP manufacturing of therapeutic products
- Excellent project integration, leadership, communication and stakeholder management skills; PMP desirable but not required
- Previous technical project management experience 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.

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2342067-2647-7921

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