Manufacturing Associate

Summary

Reporting to the Team Leader of Manufacturing, the Manufacturing Associate will participate in the manufacturing of modern cutting edge cell therapy products in the clean room cGMP compliant environment at our new Frederick facility. They are responsible for executing batch records, following SOPs and participating in the manufacturing process transfer from Company's MSAT department; they will perform the company manufacturing operations per cGMP standards. The Manufacturing Associate should be able to work in the clean room cGMP compliant environment. The person should be able to lift up to 30 pounds and be able to stay in a clean room up to 3-4 hours at a time.

Principal Duties/Responsibilities:

• Manufacture the clinical product following the batch records and standard operating procedures (SOPs) as part of a team in a GMP environment.

• Have a detailed understanding of the manufacturing process and the equipment used for production. Be able to troubleshoot common problems during cell therapy product manufacturing.

• Comply with cGMP standards and good documentation practices, timely review executed manufacturing documentation, support internal site audits per compliance standards.

• Be fully trained in required SOPs for cell therapy manufacturing and be able to train others when necessary.

• Author and revise SOPs as necessary for cell therapy manufacturing products.

• Document Deviations and CAPAs, investigate and resolve problems, identify root cause, and propose process improvements through clear communication to senior management.

• Ensure that all supplies for manufacturing are replenished and prepared for use in the clean room environment. Assist management with ensuring a steady supply of materials by actively searching for alternative products and suppliers.

Qualifications:

• BS Degree in Life Sciences or Engineering with 2-3 years' experience in cGMP production of biologics, preferably cell therapy experience.

• Excellent documentation skills, including following and completing documentation associated with cGMP manufacturing.

Work Environment:

The position requires hands-on work setting up and operating equipment in a cleanroom environment. An employee in this position works in an environment in which safety, environmental and health concerns demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles biological materials in the cleanroom environment. The employee will be required to wear appropriate personal protective equipment, including, but not limited to, eye protection, mask, coverall gown, gloves, and shoe covers. Position requires extended periods of standing, ability to lift 30 lb., and occasional weekend and holiday work.