FHCRC is seeking a Director for its recently established Therapeutic Products program, consolidating its legacy Cellular and Biological Process Development, Manufacturing, Quality Assurance and Quality Control departments. The Director will manage five 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 Director will identify personnel and training needs, and 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; assuring compliance with GMP and FDA regulations; operations and capital budgets; facilities; facilitating 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.
Chief tasks include:
- Act as central program director for the Therapeutic Products research effort. Help coordinate information flow, production scheduling, project planning and quality program structure.
- Manage five direct reporting core resource Directors/Managers and an Alliance Manager. Cores include: Process Development, Quality Control, Quality Assurance, Biological GMP Manufacturing, Cellular GMP Manufacturing.
- 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
- Masters degree or Ph.D. (Preferred)
- 10 years of experience within the pharmaceutical or biotechnology industry (preferred) or academic setting in a senior management role, optimally in a cross-functional program environment.
- Experience in the manufacturing of Cellular Therapeutic products
- 5 years in a managerial role managing a team(s) of quality individuals
- Experience in working closely with and establishing cross-functional teams to address process transfer, process improvement efforts
- Experience in large team management and budgetary responsibilities in most recent position
- Experience in developing/documenting procedures
- Project management experience
- Expert knowledge of cGMP requirements
- Prior experience in managing inspections performed by FDA and other regulatory authorities.
- Thorough understanding of quality systems
- Strong working knowledge of FDA requirements and guidance documents
- Ability to use relevant software packages to process and analyze data
- Ability to lead an organization during a period of growth and change
- Ability to establish timelines and accountability for Quality and Cross-Functional Team projects
- Excellent written and verbal communication skills
Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance are equal opportunity employers committed to workforce diversity. Diversity is essential to our pursuit of eliminating cancer and other causes of human suffering and saving lives. We support equal employment opportunity in hiring, development, and advancement for all qualified persons without regard to race, color, religion, age, sex, national origin, ancestry, physical or mental disability, veteran status, sexual orientation, gender identity, marital status, or any other protected status. Come join a team that seeks, celebrates, and leverages diversity to support our mission and strengthen our culture of creativity, innovation, and lifesaving research and patient care.