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Project Manager I/II Cell Therapy Clinical Manufacturing and PBMC Donor Program

Project Manager I/II Cell Therapy Clinical Manufacturing and PBMC Donor Program

Job ID 
10716
Type 
Regular Full-Time
Company 
Fred Hutchinson Cancer Research Center
Location 
US-WA-Seattle
Category 
Project Management

More information about this job

Overview

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. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first 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.

 

The ideal candidate acts as project manager for the routine functioning of active projects (clinical manufacturing of cell therapy products) within the TPP group.  This includes but is not limited to, running meetings, creating agendas/minutes, developing action plans, managing sub-group working meetings, identifying and tracking critical items/milestones, etc.

 

In addition, up to 25% of the effort will involve overseeing the Fred Hutch PBMC donor program and the associated donor project coordinator.  This will include overseeing recruitment, database maintenance, protocol management, and personnel management.

Responsibilities

Support the Cell Processing Facility and associated groups (QA, QC, etc.) in manufacturing Clinical supplies to treat patients for a variety of diseases, mostly related to immunotherapy. Coordinate activities between PI labs, Cell Processing Facility (CPF), Biologics Processing Facility (BPF), PD, QA, QC, and regulatory. Use technical/scientific judgement to identify agenda items, issues, risks, and actions for discussion. Track action items, deliverables, and key decisions with a level of scientific/technical understanding. Identify critical path activities, communicate effectively with scientists/technical personnel to ensure deliverable are achieved. Identify areas for program improvements, efficiencies. Manage, monitor, track, and organize scientific and process data that is generated in PI labs, development, manufacturing and QC labs during project lifecycle.

 

Interact with Seattle Cancer Care Alliance and labs at the Center to recruit healthy human subjects for research donor leukapheresis collections aiding in the ultimate production of therapeutic products used to treat patients. Activities include supervision of scheduling, potential donor recruiting, pre-screening per eligibility criteria, confirming appropriate consent status, verifying intake documentation compliance per IRB and FDA guidelines. Manage protocol data collection, product tracking and ensuring sample delivery. Maintain and grow the list of Volunteer Donors while providing regular updates to stakeholders and management. Arrange for donor payments and pertinent tax information to accounts payable while providing scoped work for invoicing to administrator. Supervise Research Donor Project Coordinator.

Qualifications

Bachelor’s degree in biology, biotechnology, life sciences, exercise science or a related field, or foreign degree equivalent; and 1-2 years of experience as a project manager, project coordinator, or researcher in biology, biotechnology, life sciences, or other related field.

 

Must also have the following experience:

      • 1 year of experience performing project management in support of biological research, immunology, cell therapy, or other related discipline. This must include preparing budgets, creating timelines, tracking milestones, and coordinating submissions (grant applications, regulatory submissions, or reports to funding agencies)
      • 2 years of laboratory experience in biological research, immunology, cell therapy, or other related discipline is strongly preferred
      • Any suitable combination of education, training or experience is acceptable
      • Experience can be gained concurrently

Our Commitment to Diversity

We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.