- 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.
- Our company is seeking a highly motivated individual with cell culture experience to work on innovative T cell therapy for cancer treatment.
- The Cell Therapy Specialist will be responsible for cell culture media preparation, cell processing and cell expansion in a cGMP clinical manufacturing facility.
- Perform all tasks associated with the manufacture of clinical product following batch records and SOPs
- Work as part of a small team to execute GMP runs in close collaboration with Product Sciences and Quality
- Assist in the development of standard operating procedures, batch records, deviations and change controls
- Successfully troubleshoot processing and equipment issues
- Other duties as assigned
- Requires Bachelor’s degree and/or advanced degree with a 3 or more years of cGMP experience in a manufacturing pharmaceutical/biotechnology environment
- Cell culture processing experience
- Previous experience with cell therapy products is a plus
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture products
- Strict adherence to SOPs and cGMP regulations, the ability to accurately complete documentation associated with clinical manufacturing
- Excellent aseptic/sterile techniques and prior experience with cell culture, cell culture equipment including Wave bioreactors
- Experience with handling and propagation of human primary cells, including T cells
- Excellent skill in Microsoft word, Excel and data analysis
- Ability to think critically, and demonstrated troubleshooting and problem solving skills
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- 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 work off-shift and long hours as required
- Ability to lift over 30 lbs.
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part of this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.