Director, Therapeutic Products Program
FHCRC is seeking a Director of Therapeutic Products to provide oversight and coordination of our six Therapeutic Products core resources and act as liaison to internal advisory committees and both internal and external customers.
The FHCRC Therapeutic Products Program encompasses Process Development, Quality Assurance, Quality Control, Cellular GMP Manufacturing, Biologics GMP Manufacturing and GMP Vector Production. Each core has a Manager/Director with approximately 50 total FTE.
This individual will have overall responsibility for pharmaceutical product development, technology transfer, business development and product manufacture according to Food and Drug Administration (FDA) guidelines, Good Manufacturing Practices (GMP) and ISO 9000 requirements for clinical trials of Investigational New Drugs (IND).
This Director will work with individual core resource managers to identify personnel and training needs, develop and motivate subordinates in product development, plant operations, facility maintenance, process and equipment validation. This Director 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 NDA 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 six direct reporting core resource managers and one project manager. Cores include: Process Development, Quality Control, Quality Assurance, Biological GMP Manufacturing, Cellular GMP Manufacturing and Vector Production.
- 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 pharmaceutical 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.
- 5 years of experience in the manufacturing of Cellular Therapeutic products
- 5 years in a managerial role managing a team(s) of quality individuals
- Lean/Kaizen/Six Sigma working knowledge
- 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 organizational growth and change
- Ability to establish timelines and accountability for Quality and Cross-Functional Team projects
- Excellent written and verbal communication skills
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