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The cGMP Research Assistant III reports to the cGMP Manager, and the Manufacturing Lead. Once fully trained, this individual will have the ability to work independently while performing specialized techniques in an FDA-regulated cGMP Core Lab. The primary job will be to manufacture cellular based products for quality and ship investigational cellular products for therapeutic use in human phase I/II clinical trials. The cGMP Technician assures all activities in the lab complies with Federal, State and local regulations and policies.

WHAT IS EXPECTED (ESSENTIAL FUNCTIONS)

Manufacturing / Production

• Performs experiments to define the cellular product(s), manufactures and QC tests and releases qualification batches and batches for human phase I/II clinical trials.
• Creates SOPs, and forms as needed.

• Performs new method development & qualification as needed.
• Assists Analytical/QC Lead during environmental monitoring activities.
• Assists in maintaining materials and reagents used for manufacturing and quality testing of cellular products using in human phase I/II clinical trials.
• Prioritizes and adjusts workflow and schedules to meet demands of multiple projects,

and assure that necessary supplies are available.

• Ensures all activities in the lab comply with federal, state and local regulations and policies.
• Responsible for laboratory records, equipment records, materials check-in records and all quality documents related to job function while adhering to cGMP, GLP and GDP.
• Assists in inventory check-in, documentation and proper storage of reagents.
• Assists with revalidating existing analytical methods and procedures.
• Involves working long hours in a clean room with restrictive gowning.
• Assume other job duties as assigned.

Cross training as an Analytical/ QC technician may also occur, however those activities will be separated from any manufacturing responsibilities so that these duties will not overlap and will follow the Analytical/QC technician job responsibilities.

QUALIFICATIONS

- EDUCATION - Bachelor's

- EXPERIENCE - 4 Years of Experience

Previous experience working in cGMP cellular processing facility and experience with clean rooms and clean room gowning is a plus