- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- We are seeking a highly motivated individual to join us as a QC Microbiology Technician in our new commercial cell therapy production center.
- You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy.
- This position provides Quality Control microbiological testing for clinical and commercial manufactured product, responsible for product testing, utility testing and environmental monitoring. The position is Sunday through Thursday, second shift.
Responsibilities (include but are not limited to):
- Perform environmental monitoring of cleanrooms
- Collect water samples
- Perform microbiological assays such as Gram Stain, Endotoxin, Sterility, Microbial Identification, Growth Promotion, Bioburden and Plate Reading
- Perform visual inspection of final product
- Data entry and trend data
- Assist in investigations regarding out of specifications (OOS) results, address and manage deviations related to micro procedures.
- Routine maintenance of lab equipment and lab spaces
- Perform other duties as required
- Bachelor’s degree in Microbiology preferred with 0 to 2 years of Microbiology lab/Environmental Monitoring experience
- Experience in the application of microbiological techniques such as air monitoring, water testing, surface monitoring, genus and species identification of various microbes
- Experience in aseptic techniques and clean room operations
- Ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
- Ability to pass vision exam for visual inspection
- Knowledge of GMP, SOPs and quality control processes
- Proficient in MS Word, Excel, Power Point and other applications
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Ability to be flexible with schedule, and work overtime as needed