Senior Director, Clinical Manufacturing And Resources

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.
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.

Fred Hutch is seeking a Senior Director, Clinical Manufacturing and Resources. This program includes GMP manufacturing of clinical grade cellular and biological products and resources supporting a wide variety of clinical trials. Clinical manufacturing includes Cell Processing, Biologics Production, Quality Assurance, Quality Control, and Process Development. Clinical Resources include Immune Monitoring and Specimen Processing. The Senior Director will manage operations and ensure the success of these critical clinical research resources.Responsibilities: The Sr. Director will have operational/financial oversight of seven core resources, including Cell Processing Facility, Biologics Production Facility, Quality Assurance, Quality Control, Process Development, Immune Monitoring and Specimen Processing. The Sr. Director will be responsible for the efficient production and quality of both research and clinical-grade cellular and biological products and appropriate processing of clinical samples to serve and anticipate customer needs. The Sr. Director reports to the Vice President, Interdisciplinary Science Administration.
Specific responsibilities include:

Leadership

• Responsible for performance and support of five resource Directors. The Sr. Director will promote continuous development of a team of manufacturing and quality professionals.
• Lead strategic planning and develop and optimize plans for staffing, plant operations, and finance that support strategic goals and ensure compliance with FDA and GMP regulations.
• The Director will report to faculty advisory committees on a recurring basis concerning current operations, finance, and future needs and plans for the facility.

Financial management and Business Development

• Responsible for operating and capital budgets in collaboration with central Shared Resources administration
• Develop and maintain appropriate rate structures, conduct yearly reviews of rates, and ensure timely and appropriate billing in all resources.
• Assess new program opportunities and ensure robust support and collaboration with external and alliance partners.

Operations

• Develop and implement the overall strategy, priorities, and quality vision. Responsible for management of physical plant, operations, and data systems.
• Ensure coordination of production scheduling, project planning and quality program structure in collaboration with the core Directors.
• Assess needs and potential to expand services in response to end user needs.
• Ensure appropriate Quality Systems are maintained, including ongoing data analysis of product and process outputs to ensure early detection of quality issues and response to quality improvement opportunities.

Customer Service

• Collaborate with all users of clinical resources to ensure the highest possible quality in the facility, assess needs for operational changes, and anticipate and plan for future operational requirements.

Qualifications:

• A Bachelor’s Degree (Master’s Degree or PhD preferred) with at least 5 years of experience in GMP manufacturing in a senior management role.
• The candidate will have at least 5 years professional experience managing senior level personnel. Strong leadership skills are required to lead clinical resources through periods of growth, change and time pressure. The ideal candidate will have a demonstrated ability to:
  • effectively lead individual teams as well as act collaboratively across an organization;
  • establish timelines, benchmark accountability and oversee program and project budgets;
  • develop and document procedures through strong project management skills and excellent written and verbal communication skills;
  • analyze data and apply an analytical framework to decision making.
• A high level of knowledge of cGMP and FDA requirements and guidance documents and a thorough understanding of quality systems is preferred, as is prior experience in managing inspections performed by the FDA and other regulatory authorities.
• Experience in the manufacturing of Cellular Therapeutic or Biological products is preferred.

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 hrops@fredhutch.org or by calling 206-667-4700.