Biomanufacturing Associate II (Cell and Gene Therapy)

Location: Waltham, Massachusetts, United States; onsite at the BaseCamp facility

Salary: $38–$52 per hour

Company

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

What you will do

• Perform routine right-first-time cGMP manufacturing of cell and gene therapy products, including aseptic processing, cell isolation, selection, culturing, cryopreservation, upstream and downstream processing, aseptic fill-finish, and final product inspection.
• Review and author SOPs and batch records, manage materials, and execute manufacturing and scale-up documentation.
• Support equipment, process, and material-flow selection and setup.
• Maintain training materials and curricula supporting continuous improvement in cell therapy manufacturing.
• Partner with Quality Assurance, MSAT, process development, facilities and engineering, and quality control to resolve deviations, CAPAs, and change controls.
• Identify improvements in safety, quality, delivery, and cost while supporting a high standard of patient and colleague safety.

Requirements

• Bachelor’s degree in biological sciences or related engineering and 2–4 years of experience in cGMP biotech manufacturing.
• Experience with aseptic techniques or processing and primary cell culture.
• Ability to work with equipment such as BSCs, microscopes, LOVO, CliniMACS, incubators, centrifuges, CRF, and G-Rex systems.
• Strong verbal and written communication, computer, Microsoft Excel, PowerPoint, and Word skills.
• Ability to work in a dynamic environment and balance multiple priorities.
• Monday–Friday, 08:00–16:00 schedule with flexibility; overtime on weekdays, weekends, and holidays may be required.

Nice to have

• Experience in cGMP manufacturing or process development for CAR-T, TCR, TIL, cell and gene therapies, or mRNA.

Culture & Benefits

• Work in a cross-functional manufacturing organization focused on advanced cell and gene therapies.
• Opportunity to adopt new technologies and contribute to building manufacturing operations.
• Physical work includes standing, walking, bending, stretching, lifting up to 50 pounds, and working while wearing PPE.
• Ability to work nights, weekends, and holidays may be required to support business needs.