ImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area (West Hills, CA), and with a subsidiary in Israel, developing novel cell therapies for treating cancer. The company’s next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment.
ImmPACT’s lead program, a bispecific “OR-gate” CAR, with an excellent tolerability profile, has demonstrated durable complete remission (CR) in 88% of patients treated so far.
ImmPACT Bio provides a generous rewards package, with competitive compensation and health benefits, with career progression benefits as part of a rapidly growing multi-platform company.
ImmPACT-Bio is seeking a highly motivated Cell Therapy Specialist to support our new T cell therapy GMP clinical manufacturing facility in West Hills, CA.
Primary Responsibilities:
- 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 Process Development, Facilities and Quality departments
- Assist in the development of standard operating procedures (SOPs), master batch records (MBRs), deviations and change controls
- Ensure right-the-first time performance of all process steps specific to the phase or state of operation, as well as drive the safety-first culture at ImmPACT-Bio
- Assist with authoring new or revise existing SOPs, MBRs, and other process documents
- Successfully troubleshoot processing and equipment issues
- Daily, real-time review of in-process cGMP documentation for completeness and accuracy
- Assist with change control and investigations required to manage deviations
- Train personnel on applicable procedures and equipment.
- Other duties as assigned
Qualifications:
- B.S./M.S. plus a minimum of 3+ years of relevant experience in a clinical manufacturing operation, manufacturing sciences, technology, or manufacturing technical support role. Cell therapy-based therapeutics such as CAR-T, or other cell-based products is a plus.
- 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 Sepax and CliniMAX
- Self-motivated, detail-oriented, good interpersonal and writing skills
- Experience with handling and propagation of human primary cells, including T cells
- Excellent skill in Microsoft Word, Excel and data analysis
- Able to work off shift hours as well as weekends as needed
- Ability to lift over 30 lbs
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture products
- Ability to think critically, and demonstrate troubleshooting and problem-solving skills
- Excellent interpersonal, verbal and written communication skills
- Ability to function efficiently and independently in a changing environment
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies for cancer patients who have exhausted their treatment options. The company’s logic-gate-based CAR T platforms address key biological challenges in treating cancer. ImmPACT Bio’s technologies are specifically designed to prevent antigen escape, prevent ‘on-target – off-tumor’ toxicities, and overcome the immunosuppressive tumor microenvironment.