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 and largest 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.
The Cell Processing Facility Supervisor will provide direct technical and supervisory leadership to the group as well as indirectly to the entire cell therapy development and manufacturing organization
SCOPE OF RESPONSIBILITIES
This position, reporting to the Manufacturing Manager, is responsible for leading the cGMP manufacturing team in the production of cellular and gene therapies in support of clinical research studies. The successful candidate will oversee a team of professional associates responsible for the cGMP manufacture of cell and gene therapies within the Cell Processing Facility (CPF). The successful candidate will address operational and routine challenges as they arise for Phase I/II and potentially Phase III manufacturing. Knowledge of cell culture / aseptic operations / cell and gene therapy manufacturing and support systems is essential. Demonstrated leadership and communication skills along with a strong working knowledge of the regulatory compliance requirements for the production of cell and gene therapies used in clinical studies are essential.
- Responsible for daily activities required for successful operation of CPF including: ensuring batch production activities follow all documentation and Standard Operating Procedures (SOPs).
- Responsible for cGMP compliance, ensuring that all production equipment is properly working and production processes meet quality standards.
- Assigns tasks to production associates to ensure completion of daily and weekly manufacturing schedules.
- Responsible for training new employees on areas of technical expertise and compliance issues relevant to the manufacturing setting.
- Participates in hiring, training, supervising and evaluating staff.
- Develop goals for direct reports on an annual basis and routinely monitor progress against those objectives. Conduct annual performance reviews of direct reports.
- Works closely with the production staff to troubleshoot process and equipment problems
- Working with manufacturing and technical staff, create, revise, and edit SOPs, batch records and raw material and product specifications as needed.
- Manages, plans and reviews operations for assigned staff, including responsibility for training, managing and evaluating as well as coordinating, scheduling and assigning work and maintaining facility's standards.
- Maintains production schedule to meet customer and business goals.
- Communicates status of operations, safety and maintenance problems, in a timely manner to Area Management
- Bachelor's degree in Biology, Chemistry, or related Science major required and 2-4 years of experience in a cell therapy/biologics facility or equivalent.
- Direct experience in aseptic processing techniques and a throughout understanding of cell therapy/gene therapy clinical manufacturing required.
- Has a thorough understanding of cGMP requirements for clinical manufacturing.
- Ability to work with limited supervision and to handle problems of a more difficult nature.
- Excellent communication skills, both oral and written.
- Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
- Meets physical requirements of the job, as follows: must have the ability to lift a minimum of 50 pounds, the ability to bend, reach, stretch, climb ladders and work in tight spaces in order to complete job tasks.
- Must have the ability to stand for long periods.
- Must be able to wear appropriate clean room attire and have the ability to wear surgical masks and all Personal Protective Equipment (PPE).
May be required to travel on rare occasions for offsite training, customer meetings and technical transfer discussions.
We are a VEVRAA Federal Contractor
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