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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.
Working within the Therapeutic Products Program (TPP),the TechnicalProductManager is responsible formanaging theportfolio ofTPPcell therapyproductsfrom developmentphaseto patientdelivery.This role provides program support toall TPP departments including Quality Control, Quality Assurance, Cellular Processing Facility, and Biologics Processing Facility.The TechnicalProductManager partners withexternalcompanies, Principal Investigators, andcross-functional center groups such as the IIRC Project Management Office, ISIOC, Shared Resources, and Business Development, and other key stakeholderstosupportdelivery ofhigh-quality phase I/II cell therapy products to patients. This position requiresstrong cell therapy technical knowledge and project management skills to drive thefullproductlifecycleand to support the strategic and operational vision of the TPP organization.
The successful candidate will be responsible for the overall strategy and management of complex TPPcell therapy productsandassociatedtechnicalprojects, including the development of new processes in support of the program:
Collaborate with facility Directors to develop a strategy to bring end user products to clinic: develop product roadmap and timelinesfor new projects, and contribute toproductimplementation needs,manage change,projectwork scope, and budgeting
Translate development, manufacturing, quality, CMC, and regulatory activities into clear operational tasks by assigning task owners, track progress, communicate status, and ensure tasks are executed on time and to specification
Optimize team meetings and facilitate effective governance and decision making across the collective functional teams, ensuring meeting participants have the information and structure necessary to be productive and engaged
Develop and implementtools, processes,and systems(lifecycle improvements)to increaseprojectefficiency, manage change, and trackprojectand product status and associated deliverables
Identify and communicatekeyprojectrisks and their associated mitigation and contingency plans.Manage scope of work and ensure project activities are aligned with overall project goals and client expectation;provide technical guidance to evaluate program feasibility
Coordinate developmentanddeliveryofSection 7 (CMC) of INDfor new drug productapplicationsand associatedsupportive data and appendix documentationrequired forsuccessful IND submittal
Develop and maintain a pipeline of process improvement projects that span TPP departments
Coordinate cross-departmental teams to support implementation ofnew drug products orprojects that span TPP departments
Maintain relevanttechnical and scientific knowledge within the field of immunotherapy, including current technology trends, changing compliance guidance, and research/development
Coordinate product-specific cross-departmental presentations and analyses, for both internal and external audiences, includingproviding guidance on data compilationto deliverengaging, compelling,informativeand well-organized presentations that drive defined decisions and actions
Create a positive team environment that instills trust, acknowledge individual contributions, encourage team engagement
4+years of experience in CMC process developmentand/orGMP manufacturing
4+ years of relevant laboratory experience in biological research, immunology, cell therapy, or other related discipline
Bachelors degree in biology, biotechnology, life sciences, or a related field, or foreign degree equivalent
Additionalprojectmanagement training and/or certificationis strongly preferred
Highly effective team player and excellent communicator with an ability to interact with and influence internal and external stakeholders and work with scientists and executives with diverse information needs and communications preferences
Strong organizational and problem-solving skills
Advanced meeting organization and facilitation skills
Experience with managing multiple project portfolios
Knowledge of and demonstrated experience with Project Management methodologies, strategies,and tools
Advanced experience with key project artifacts, such as charters, project plans, risk matrices, dashboards, and roles and responsibilities documents (e.g., RACIs)
Advanced computer skills and deep experience with at least one Project Management software tools(e.g., Microsoft Project, Basecamp,SharePointetc.)
Key Skills, Knowledge and Experience:
Resolves and/or escalates issues to appropriate management in a timely fashion
Understands how to communicate difficult/sensitive information tactfully
Identifies opportunities for improvement and makes constructive suggestions for change; manages the process of innovative change effectively
Remains on the forefront of emerging industry practices
Continually seeks opportunities to increase customer satisfaction andstrengthenclient relationships
Develops strong technical and business relationships with external partners and serve as an advocate for the organizations interests
Develops and maintains productive internal relationships
Facilitatescross-collaboration and understanding between TPP and other departments
Seeks and participates in personal development opportunities above and beyond training required
Complies with and helps to enforce standard policies and procedures
Influencesothers acrossboth TPP and the larger team members within Fred Hutchto remain focused on desired outcomes without direct authority
Clearlydeciphertechnical needs of clients, PIs,and departments within TPPto inform productspecification androadmap
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through work at Fred Hutch is requested of all finalists.
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 firstname.lastname@example.org 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.