The Seattle Cancer Care Alliance (SCCA), located in Seattle, Washington, is part of a dynamic collaboration among three organizations known nationally and internationally for their patient care and research: Fred Hutchinson Cancer Research Center, University of Washington, and Seattle Children's. Over the past 25 years, these institutions have worked together to support their mission of adult and pediatric oncology patient care services, research and education.
The Cellular Therapy Lab (CTL) at the Seattle Cancer Care Alliance (SCCA) is on the cutting edge of new technologies for cancer therapy, including cell-based immunotherapy. We are committed to advancing treatment options for our patients through the translation of innovative research into clinical practice. We collaborate with our Alliance partners (University of Washington, Fred Hutchinson Cancer Research Center and Seattle Childrens Hospital) as well as industry (biotechnology) and non-industry external entities.
CTL is responsible for all minimally manipulated therapeutic cell processing occurring at the SCCA for standard therapies, clinical trials and commercial cell therapeutics. Procedures range from cryopreservation to flow cytometric enumeration of cell proportions to more complex procedures such as cell selections, including enrichment and depletion. The laboratory is regulated by the FDA cGTP/cGMP standards, maintains College of American Pathologists (CAP) certification, and is accredited by the Joint Commission and FACT.
Employees must adhere to all SCCA policies and processes, including the SCCA Code of Conduct and all HIPAA privacy requirements.
Based on review and synthesis of clinical trial/commercial product documents and existing CTL SOPs, draft SOPs specific for clinical trial and commercial products in CTL. Conduct and/or assign training as needed based on information gathered from sponsor product manual, protocol, and research team.
Represent Cellular Therapeutics (CTP) department in associated cell-based clinical trials with Alliance members and/or external sponsors to ensure successful implementation and maintenance as a part of the Clinical Trial Team in conjunction with guidance from CTP Management and Clinical Trial Operations Manager (CTOM).
Serve as a back-up Cellular Therapeutics representative for the CTOM for operational discussions, correspondence and committees, as required. This may include but is not limited to Operational Feasibility meeting, protocol implementation committee meeting, and cross-functional scheduling meetings. Communicate key outcomes from those meetings to the CTP Clinical Trial Team members, as needed.
Coordinate and facilitate activities related to the lifecycle of the clinical trial with guidance from CTOM. Activities include, but are not limited to maintenance of study-related documents, document revisions, training, scheduling, data collection, and coordination of processing and monitoring visits.
Review, research, and present literature associated with clinical trials technology and theory to staff.
Assist in coordination activities for the CTP Clinical Trial Team to handle implementation and maintenance activities, to track clinical trial status, activity and timelines.
In support of the CTP Clinical Trial Team, assist with the implementation of FDA approved cellular therapeutics (commercial products).
Provide technical service summaries to the Associate Director and Administrative Manager of CTP for contracting and finances, as needed.
Communicate with the Cell Therapy Medical, Scientific Directors and Administrative and Quality Associate Directors about clinical trials to seek or provide information, as needed.
Work with CTOM and CTL Management to learn about and address feedback from staff on issues or concerns regarding protocols.
Serve as a technical reference to assist with training and support operations
Responsible for knowledge of current FDA regulations or applicable accreditation standards in relation to applicable processes.
BA or BS in relevant major/field
3+ years experience with cellular therapeutics, both theoretical and practical in the laboratory or 5+ years in biologics research and development and/or manufacture
Experience in the implementation of clinical trials and/or commercial products.
2+ years lab coordination experience
Knowledge of basic hematology and immunology theory
Experience with magnetic bead-based cell selections, depletions
Experience reviewing clinical protocols, product manuals and other clinical trial/commercial product documents
Strong capabilities in training staff at a variety of levels
Experience writing and reviewing technical documents
Working knowledge of relevant regulations and standards, including cGTP and cGMP
High level of motivation and initiative
Ability to work independently, but also a member of a high-functioning team
Strong attention to detail
Collaborate and communicate effectively internally and externally across functions and organizations
Strong computer skills with proficiency in all MS Office programs
Experience in research and development, both academic and industry
Experience working with FACT and CAP accreditation standards
Experience in materials management
Process improvement, Six Sigma, Lean experience
Process development experience
Experience in facilitation of cross-functional projects
Project coordination or project management experience
Formal Project Management training, introductory or beyond
Experience with OneNote and Teams
Basic finance experience a plus
Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, 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 [email protected] or by calling 206-667-4700.
At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.