Biomanufacturing Associate

Position Summary

The Manufacturing Associate – Cell Therapy will support daily operations in a GMP-regulated environment to produce cutting-edge cell therapy products. This role is responsible for executing manufacturing processes, maintaining compliance with quality and safety standards, documenting activities with high accuracy, and contributing to continuous improvement initiatives. The ideal candidate has foundational experience in pharmaceutical or biotechnology manufacturing and a strong commitment to operational excellence.

Key Responsibilities

• Execute end-to-end cell therapy manufacturing processes, including cell culture, aseptic processing, media preparation, and formulation.
• Operate and maintain equipment such as biosafety cabinets, incubators, bioreactors, centrifuges, and environmental monitoring devices.
• Perform batch record documentation, logbooks, and GMP-compliant data entry with precision and completeness.
• Follow standard operating procedures (SOPs), batch production records (BPRs), and aseptic technique best practices.
• Assist in troubleshooting equipment or process deviations and support root cause investigations.
• Maintain cleanroom gowning qualifications and adhere strictly to cleanroom protocols.
• Collaborate with cross-functional teams such as Quality Assurance, Quality Control, and Supply Chain to ensure smooth production execution.
• Participate in training programs and contribute to continuous improvement efforts for safety, quality, and efficiency.
• Support inventory management, material preparation, and equipment calibration activities.

Required Qualifications

• Degree in Biology, Biotechnology, Bioengineering, Chemistry, or related scientific discipline.
• 1 year of experience in pharmaceutical, biotech, or cell therapy manufacturing in a GMP environment.
• Working knowledge of aseptic technique and cleanroom operations.
• Ability to follow detailed procedures and maintain accurate documentation.
• Experience with cell culture, viral vectors, or autologous/allogeneic cell therapy processes.
• Familiarity with electronic batch records (EBR), LIMS, or MES systems.
• Understanding of FDA, EMA, and ICH quality and compliance guidelines.
• Ability to work flexible hours, including occasional weekends or shift work.