Manufacturing Associate II

Responsibilities:

• Perform complex manufacturing operations according to Standard Operating Procedures (SOPs) and batch records, including cell culture, viral vector production, purification, and formulation.
• Operate and maintain manufacturing equipment and instrumentation, ensuring proper calibration and functionality.
• Execute aseptic techniques and maintain cleanroom environments to ensure product integrity and minimize contamination risks.
• Conduct in-process testing and monitoring of critical process parameters to ensure product quality and consistency.
• Collaborate with cross-functional teams including Quality Assurance, Quality Control, Process Development, and Engineering to troubleshoot issues and optimize manufacturing processes.
• Complete manufacturing documentation accurately and in a timely manner, including batch records, logbooks, and inventory records.
• Participate in process improvement initiatives and assist in the implementation of new technologies and methodologies to enhance manufacturing efficiency and productivity.
• Follow all safety protocols and adhere to regulatory requirements (e.g., cGMP, FDA guidelines) to ensure a safe and compliant work environment.
• Mentor and train junior manufacturing technicians to develop their skills and knowledge in gene and cell therapy manufacturing.

Qualifications:

• Bachelor’s degree in Biology, Biochemistry, Chemical Engineering, or related field.
• Minimum of 3 years of experience in a biopharmaceutical or biotechnology manufacturing environment, preferably with experience in gene and cell therapy manufacturing.
• Strong understanding of cell culture techniques, viral vector production, and purification processes.
• Proficiency in aseptic techniques and working in cleanroom environments (ISO 7/8).
• Experience operating and troubleshooting manufacturing equipment such as bioreactors, centrifuges, chromatography systems, and filtration systems.