GMP Cell-Based Manufacturing Specialist I

ACTalent; Ohio; On-site; USD 60,000 - 85,000; Full time

Job summary

ACTalent is seeking a GMP Scientist I / GMP Operations Technician I to support cell-based manufacturing in a Clinical Manufacturing facility. You will execute GMP processes, manage batch records, and maintain GMP-compliant documentation in a fast-paced, start-up-phase environment.

The role emphasizes hands-on production in the lab and clean room, collaboration with GMP leadership, and ongoing process improvements while adhering to SOPs and regulatory standards.

Qualifications

• Experience in aseptic processing or GMP manufacturing environments.
• Background in drug compounding, drug manufacturing, or FDA-regulated food manufacturing.

Responsibilities

• Support GMP operations and production in the Clinical Manufacturing facility, focusing on cell-based manufacturing.
• Execute GMP and Viral Vector Core production processes per batch records and SOPs.
• Assist with day-to-day manufacturing to ensure timely, compliant delivery of biological products.
• Support GMP resources and supply chain by ordering materials and maintaining inventory.
• Ensure materials have proper documentation and traceability per GMP requirements.
• Collaborate with GMP management to identify improvement opportunities using metrics and statistical tools.
• Operate lab equipment and systems per SOPs, including calibration and cleaning.
• Assist in reviewing and updating batch records and SOPs.
• Support change controls by documenting changes and maintaining GMP compliance.
• Spend 50–75% time in the lab and clean room performing hands-on production activities.
• Spend 25% time on documentation and preparation for upcoming steps.
• Follow aseptic techniques and clean room procedures to maintain a compliant environment.
• Handle materials and equipment safely, occasionally lifting 30–45 pounds.
• Collaborate with a diverse team in a growing start-up-phase operation.

Skills

Aseptic processing

GMP manufacturing

Cell culture

Lab equipment operation

Attention to detail

Teamwork

Documentation

Education

Associate’s degree in science

Job description

ACTalent is seeking a GMP Scientist I / GMP Operations Technician I to support cell-based manufacturing in a Clinical Manufacturing facility. You will execute GMP processes, manage batch records, and maintain GMP-compliant documentation in a fast-paced, start-up-phase environment.

The role emphasizes hands-on production in the lab and clean room, collaboration with GMP leadership, and ongoing process improvements while adhering to SOPs and regulatory standards.