The incumbent in this position is responsible for highly complex and specialized manufacturing of cellular products for clinical use. In addition, this individual will be responsible for supporting the daily operation of the CCBB facility to ensure it is in control and in compliance with applicable regulations. The individual filling this position will be an integral member of a team working together to produce the highest quality clinical products for hematopoietic cellular transplantation.
WORK PERFORMED:
Perform duties as dictated by standard operating procedures (SOPs) for the manufacturing of licensed DUCORD product and other hematopoietic cellular products, including but not limited to bone marrow and peripheral blood stem cells for clinical use under cGMP guidelines as directed. Utilize a biological safety cabinet and employ aseptic technique. Operate manual and automatic instrumentation needed for cell manufacturing including but not limited to cell separators, cell counters, centrifuges, incubators, pipettes, and LN2 freezers. Accurately complete batch record documentation, and all appropriate equipment log entries. Participate in Proficiency Testing surveys as applicable. Maintain responsibility and donor confidentiality.
Work with Lab Manager, other CCBB Manufacturing Technicians, and Quality Systems Unit to ensure the facility is in compliance for governing regulations. Maintain orderly lab spaces. Participate in lab inspections and work with inspectors as needed. Record and inform of any insufficient inventory of supplies and reagents; clean and maintain laboratory equipment in good working order.
Use knowledge of laboratory safety and infection control procedures and practices to safely perform required work including universal precautions and hazardous chemical handling.
Use dexterity, knowledge, and ability to complete assigned laboratory tasks and skills, with attention to detail and compliance with all appropriate laboratory regulatory and safety requirements.
Ability to work and maintain strong relationships with the department manager, members of the CCBB team and other departmental staff. Attend routine laboratory and departmental meetings.
Ability to read and understand Standard Operating Procedures. Complete assigned training and required competency and proficiency assessments. Complete required continuing education hours.
Perform other related duties incidental tithe work described herein.
Preferred Skills
Good communication skills and the ability to work independently as well as part of a team. Communicate and interact in a professional and courteous manner with co-workers, and others. Must be team oriented and able to work in a highly collaborative work environment to complete complex tasks. Must be able to manage multiple and rapidly changing priorities and have the ability to quickly learn new skills and concepts.
Minimum Qualifications
Education
Work generally requires a bachelor’s degree in science, engineering, or related field.
Experience
None required above education/training requirement. Prefer up to two experience. years of laboratory experience, preferably in a GMP/regulated environment. A related master’s degree may substitute for two years of experience.
