Associate II, Biomanufacturing (Cell and Gene Therapy)

Location: Waltham, Massachusetts, United States; onsite at the manufacturing site

Salary: $38–$52 per hour

Company

hirify.global is a technology-driven biotechnology company developing integrated technologies, services, and manufacturing capabilities for advanced therapies from design through commercialization.

What you will do

• Perform and lead right-first-time cGMP manufacturing of cell and gene therapy products, including CAR-T cells, iPSCs, AAV, and lentivirus.
• Execute aseptic processing, cell isolation, selection, culturing, cryopreservation, upstream and downstream processing, aseptic fill-finish, and final product inspection.
• Support manufacturing start-up by authoring SOPs, batch records, reports, risk assessments, and material management documentation.
• Train colleagues on equipment, processes, material flows, and manufacturing procedures.
• Partner with process sciences, development, facilities and engineering, technical operations, quality control, and quality assurance teams to support technology transfer.
• Manage batch data and reports, resolve deviations and CAPAs, support change controls, and identify process, safety, quality, and cost improvements.

Requirements

• Bachelor’s degree with at least 2 years of related experience, or a master’s degree with up to 1 year of related experience.
• Experience with cGMP manufacturing or process development for CAR-T, TCR, NK, cellular therapies, AAV, LV, or RV is preferred.
• Proficiency in aseptic technique or processing and an understanding of primary cell culture.
• Ability to use manufacturing equipment such as CliniMACS, LOVO, bioreactors, chromatography skids, TFF systems, WAVE bioreactors, Xuri, and G-Rex.
• Strong verbal and written communication skills, plus proficiency with Microsoft Excel, PowerPoint, and Word.
• Ability to work in a dynamic environment, balance multiple priorities, work nights, weekends, and holidays as needed, and meet physical requirements including prolonged standing and lifting 15–20 lbs.

Culture & Benefits

• Regular employment at a state-of-the-art manufacturing facility.
• Cross-functional collaboration focused on safety, quality, and patient impact.
• Opportunity to contribute to the build-out of new manufacturing operations and adopt new technologies.
• Work in a cGMP environment with a focus on continuous improvement and right-first-time execution.