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We are seeking a Director for our recently established Therapeutic Products Program. The Director will manage seven individual core resource Managers/Directors in Process Development, cGMP cellular manufacturing, Quality Control, cGMP biological manufacturing and Quality Assurance. This position will also coordinate and direct an Alliance Manager who is responsible for external customer relations and coordinating activities between the individual resource cores and faculty.
The Therapeutic Products Program Senior Director will have overall ownership for the end-to-end production of both research and GMP clinical-grade Biological and Cellular products. The Senior Director will evaluate training needs, develop and motivate subordinates in product development, plant operations, and process and equipment validation and is also responsible for optimizing production of existing product manufacturing and assuring compliance with GMP and FDA regulations. He/she will develop and have responsibility for operating and capital budgets, facilities planning and operations, technology and manufacturing process transfer, providing product for applicable clinical trials as required to support US IND filings and supporting program development as appropriate to decisions regarding market opportunities. This position will report to the VP of Shared Resources and work closely with both programmatic advisors and relevant faculty.
Specific responsibilities will include:
- Act as the central program director for the Therapeutic Products research effort, coordinating information flow, production scheduling, project planning and quality program structure.
- Evaluate new Program opportunities, both for internal and external clients.
- Manage seven direct reporting core resource Directors/Managers and an Alliance Manager. Cores include: Process Development, Quality Control, Quality Assurance, - Biological GMP Manufacturing, Cellular GMP Manufacturing, Immune Monitoring and Alliance Management. The Senior Director will work closely with the managers and directors to ensure that all teams have adequate support, resources and able to lead initiatives as these teams continue to grow and to build out the Therapeutic Products - Program as needs dictate and in synchrony with institutional strategic initiatives.
- Establish and ensure appropriate Quality Systems are implemented and maintained, including ongoing data analysis of product and process outputs to ensure early detection of quality issues and response to quality improvement opportunities.
- Work with other Quality/Compliance, Operations, Planning, Logistics, Purchasing and Finance managers and personnel to effectively create and support process and quality enhancement initiatives.
- Create and maintain an environment of excellence, world-class quality and continuous improvement throughout the entire program, which includes executing and maintaining a clear quality vision and strategy for the site in conjunction with the oversight committees.
- Make fact-based, scientifically sound, quality decisions regarding products manufactured at the facility within the requirements of cGMPs and applicable regulatory/industry guidance documents.
- Supply the highest level of internal and external customer service and measure this through the maintenance and communication of site quality metrics.
- Lead the application of appropriate quality technology tools to establish and maintain process capability, and support systems for current manufacturing.
- Bachelor's Degree
- At least 10 years of experience within the pharmaceutical, biotechnology industry (preferred), or academic setting in a senior management role
- At least 5 years of professional experience in a leadership position that required the management of senior level personnel and a demonstrated ability to effectively lead individual teams and cross-platform technologies to address process transfer and process improvement efforts
- Experience with establishing timelines, benchmarking accountability and overseeing program and project budgets
- Demonstrated high level of knowledge of cGMP and FDA requirements and guidance documents, as well as a thorough understanding of quality systems
- Prior experience managing inspections performed by the FDA and other regulatory authorities
- Master's Degree or PhD
- Experience within a GMP production cross-functional program environment
- Experience in the manufacturing of Cellular Therapeutic products
- Ability to use relevant software packages to process and analyze data
Key Skills and Abilities
- Ability to develop and document procedures
- Strong project management skills, as this position will require an individual to lead the group through periods of growth, change and time pressure
- Excellent written and verbal communication skills
To apply for this position, please CLICK HERE