Manufacturing Technician

Title: Manufacturing TechDuration: 1 year contractLocation: Berkeley, CAPOSITION SUMMARY-Responsible for clinical manufacturing of monoclonal antibodies (mAB) Drug substance within the Cell Culture Technology Center (CCTC). Collaborates closely with biological development (BD) and Manufacturing Science and Technology (MSAT) for new product introductions and ensure platform alignment.Key Responsibilities:Facility Maintenance & Compliance:Maintain the manufacturing floor to GMP standards, ensuring it remains audit-ready.Organize and manage disposables, including the disposal of expired items and restocking of everyday materials and equipment.Conduct routine facility checks and upkeep using the Encompass system.Environmental Monitoring:Support environmental monitoring activities during processing, including the handling and testing of environmental monitoring plates.Ensure adherence to aseptic techniques and processes for maintaining Class B, C, and D cleanroom standards.Equipment Maintenance:Perform regular cleaning and maintenance of manufacturing equipment, such as biosafety cabinets, microscopes, incubators, pH conductometers, and flex cell counters.Monitor and maintain equipment logs to ensure consistent performance.Documentation & Compliance:Review and update DSD shift books and ensure accurate documentation entries on a monthly basis.Support process documentation in compliance with GDP standards.Operational Support:Spend approximately 50% of time on the manufacturing floor and 50% on administrative tasks.Assist with training team members in GMP compliance, environmental monitoring, and operational protocols.Qualifications:Education: Bachelor's degree in a relevant scientific discipline required.Experience:Hands-on experience in manufacturing or as a manufacturing technician.Strong understanding of GMP, GDP, and pharmaceutical/biotechnology operations.Familiarity with environmental monitoring and aseptic techniques.Experience with SAP and cell culture or cell therapy processes is a significant advantage.Technical Skills:Proficiency with analytical equipment, including microscopes, biosafety cabinets, flex cell counters, and incubators.Knowledge of Class B, C, and D cleanroom standards is highly preferred.Exact compensation may vary based on several factors, including skills, experience, and education.Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Created: 2025-01-25