Monoclonal Antibody Clinical Manufacturing Technician

Insight Global; Berkeley (CA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

HSA, FSA, and DCFSA accounts

401k retirement account with employer

Paid sick leave and/or PTO as provided

Job summary

Insight Global seeks a Clinical Manufacturing Specialist for monoclonal antibody drug substance production. You will own all aspects of clinical manufacturing from cell culture and expansion to filling, QC, and documentation in a GMP environment.

Collaborate with BD and MSAT for new product introductions, maintain batch records, SOPs, and logbooks, and ensure GDP-compliant documentation. This role involves 12-hour shifts and work in a Class B cleanroom environment; competitive benefits apply.

Qualifications

• Hands-on experience on a manufacturing floor with exposure to downstream development.
• Experience with GMP processes, familiarity with SAP, and ability to handle 12-hour shifts.
• Experience working in cleanrooms and fully gowning.
• Experience with Batch Production Records (BPRs), SOPs and log books in GDP-compliant documentation.

Responsibilities

• Responsible for all aspects of clinical manufacturing in areas: Cell Expansion, Cell Culture, Differentiation, Filling, Visual Inspection, Solution Preparation and Weigh/Dispense.
• Cell Culture Maintenance: prepare and maintain cell culture environments, media prep, cell counting, growth monitoring.
• Quality Control: perform quality checks following protocols to prevent contamination.
• Data Recording: accurately record data on cell growth and production metrics.
• Collaboration: work with QA and Production teams to meet production targets.

Skills

Manufacturing Experience

GMP and GDP

Experience with cleanrooms

Documentation

Tools

SAP

Job description

Insight Global seeks a Clinical Manufacturing Specialist for monoclonal antibody drug substance production. You will own all aspects of clinical manufacturing from cell culture and expansion to filling, QC, and documentation in a GMP environment.

Collaborate with BD and MSAT for new product introductions, maintain batch records, SOPs, and logbooks, and ensure GDP-compliant documentation. This role involves 12-hour shifts and work in a Class B cleanroom environment; competitive benefits apply.