Biomanufacturing Associate II (Contract, Monday-Friday)

Location: Waltham, Massachusetts, United States; onsite at the BaseCamp facility. Monday-Friday, 9:00 a.m.-5:00 p.m., with overtime, nights, weekends, and holidays as needed.

Salary: $38-$52 per hour, depending on level, qualifications, experience, and training.

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 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 and selection, cell culture, cryopreservation, upstream and downstream processing, aseptic fill-finish, and final product inspection.
• Support manufacturing start-up activities by authoring SOPs, batch records, reports, and risk assessments, and managing materials.
• Train team members on equipment setup, processes, and material flows, and maintain clean rooms in an organized, ready state.
• Collaborate with process sciences, development, facilities and engineering, technical operations, quality control, and quality assurance teams on technology transfer.
• Manage batch data and reports, resolve deviations, CAPAs, and change controls, and identify process, safety, quality, and cost improvements.

Requirements

• Bachelor’s degree in biological sciences or a related engineering field.
• At least 2 years of experience in cGMP biotechnology manufacturing, preferably in cell and gene therapies.
• Experience with cGMP manufacturing or process development for CAR-T, TCR, NK, cellular therapies, AAV, LV, or RV.
• Advanced understanding of primary cell culture and experience with relevant manufacturing equipment, including CliniMACS, LOVO, bioreactors, chromatography skids, TFF, WAVE bioreactors, and G-Rex systems.
• Proficiency in aseptic technique or processing, strong communication skills, and proficiency with Microsoft Excel, PowerPoint, and Word.
• Ability to work in a dynamic manufacturing environment, balance multiple priorities, and meet physical requirements including standing, walking, lifting, and working in PPE.

Nice to have

• At least 2 years of project leadership experience.
• Experience with a broad range of cell and gene therapy manufacturing processes.

Culture & Benefits

• Contract position within the Manufacturing department.
• Cross-functional collaboration focused on high safety and quality standards for colleagues and patients.
• Opportunity to contribute to the development of a new manufacturing operation and adopt new technologies.
• Overtime and schedule flexibility may be required to support business needs.