Cell Biologist - Cellular Therapy Laboratory and Bio Bank
Education / Experience
· Minimum of (2) years’ experience in cell and gene therapy.
· Completion of a Master’s degree program in chemistry or biology.
· Minimum (2) years’ experience of flow cytometry and cell culture.
Summary Statement
The biologist exercises significant independent judgment, initiative and decision making, extreme accuracy and attention to detail, as well as the ability to adjust to a flexible and sometimes unpredictable work schedule. The work requires specialized training and clinical grade sterility, as well as manual and automated processing. Knowledge of potency assay and flow cytometry. Ability to document in adherence with GMP/GDP guidelines.
Responsibilities
Routine Duties
· Training and development as needed.
· Adhere to GMP/GDP/GTP guidelines.
· Process allogeneic HPCs in accordance with established procedures and protocols.
· Performs calculations during processing to assess product yields.
· Uses aseptic techniques while performing cell processing procedures
· Investigate and resolves problems with procedures or processes.
· Perform flow cytometry to assess viability and phenotyping.
· Communicates with Scientific Director to coordinate, schedule and perform processing of HPCs.
· Maintains accurate inventory of cryopreserved products for transfusion and for further manufacturing.
· Ensure documentation is accurate, complete, comprehensive, and maintained.
· Collects and labels required laboratory samples and creates and maintains accurate and complete result reports, processing worksheets, and cryopreservation records.
· Performs quality control and preventative maintenance on instruments and equipment and maintains compete and accurate records.
· Practices proper safety techniques and reports any unsafe conditions to management.
· Other duties and procedures as assigned.
Knowledge, Skills and Experience
· Experience in cGMP and cGTP requirements (preferable)
· Understanding of applicable FDA regulations, AABB cellular therapy standards, and other relevant regulatory and accreditation requirements.
· Experience in cell and gene therapy
· Experience in minimal and more than minimal manipulation of cellular therapy products.
· Experience in flow cytometry assays (required)
· Knowledge of sterile techniques required for cellular therapy product handling and manipulation.
· Knowledge of the use of liquid nitrogen, to provide a safe, compliant, and cost-effective cryogenic environment.
· Demonstrate ability to perform standard data analysis and calculations.
· Demonstrate ability to make independent decisions within established parameters.
· Demonstrate ability to prioritize required duties and responsibilities.
· Excellent oral and written communication skills.
· Strong organizational skills with attention to detail.
· Ability to work both independently and within teams.
· Time management skills.
· Flexibility to adjust to changes in schedules, working hours and procedures. Positon may require extended hours at intervals.
· Ability to work high stress situations.
Travel
As needed to attend relevant industry conferences to meet continuing education requirements.
Physical Demands / Working Conditions
This position requires walking, standing, stooping, lifting, and using tools requiring high dexterity. Occasional lifting of objects weighing in excess of 20 pounds. Travel may also be required. Exposure to infectious diseases, hazardous chemical and materials, needle sticks, blood and body fluids.
This job description is not intended to be all inclusive. Duties and/or responsibilities may be added or deleted as management requires to meet the ongoing needs of the organization.