Career Opportunities in the Foresite Capital Network

ImmPACT Bio is looking for an exceptional individual to join our growing team as a Cell Therapy Specialist II. This position will report directly to the Supervisor, Manufacturing and be responsible for the manufacturing of clinical product.

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

Preferred Qualifications:

• B.S./M.S. plus a minimum of 2+ 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