Cell Therapy Specialist III
ImmPACT Bio USA
ImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area, developing novel cell therapies for treating cancer and autoimmune disease. 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 Bio is looking for an exceptional individual to join our growing team as a Cell Therapy Specialist III. This position will report directly to the Supervisor, Manufacturing and be responsible for the manufacturing of clinical product.
- 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
- 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
Compensation for the role will depend on several factors, including a candidate’s qualifications, skills, competencies, and experience.
ImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs. ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. All information will be kept confidential according to EEO guidelines.