Associate II, Biomanufacturing (Contract)

Location: Waltham, Massachusetts, at the BaseCamp facility. Rotating 12-hour day shifts from 07:00 to 19:00, with overtime on weekdays 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-Ts, 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, risk assessments, and material orders.
• Train colleagues on equipment, process and material flows, and maintain cleanrooms in an organized, ready state.
• Collaborate with process sciences, development, facilities and engineering, technical operations, quality control, and quality assurance on technology transfer.
• Manage batch data and reports, resolve deviations, CAPAs, and change controls, and identify improvements in process, safety, quality, and cost.

Requirements

• Bachelor’s degree in biological sciences or related engineering.
• At least 2 years of experience in cGMP biotechnology manufacturing for the Associate II level, preferably in cell and gene therapies.
• Experience with cGMP manufacturing or process development for CAR-T, TCR, NK, cellular therapies, AAV, LV, or RV products.
• Advanced understanding of primary cell culture and experience with equipment such as CliniMACS, LOVO, bioreactors, chromatography skids, TFF, WAVE bioreactors, Xuri, or 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, work rotating shifts, and meet physical requirements including standing, lifting, climbing, and working in PPE.

Nice to have

• At least 2 years of project leadership experience.

Culture & Benefits

• Opportunity to contribute to the development of a new manufacturing operation for advanced therapies.
• Cross-functional collaboration across manufacturing, process sciences, engineering, technical operations, and quality functions.
• Commitment to high safety and quality standards for colleagues and patients.
• Work may include nights, weekends, holidays, and overtime to support business needs.