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Production Associate

Summary:
Cytonet LLC, a company specializing in the manufacturing of primary liver cells for cell therapy applications in the US and Europe in the field of cellular and biological therapeutics is seeking an entry level Production Associate.

Essential Functions:

- Production of human primary cell using accompanying documentation according to GMP guidelines.

- Maintenance and cleaning of equipment.

- Preparation of materials for washing and sterilization

- Maintenance, cleaning, and environmental monitoring of GMP/clean room areas and

- Reviewing and revising of operating protocols, reports and SOPs according to GMP guidelines.

- Execution of process validations for the production of human primary cells.

- Maintenance of documentation and logbooks.

- Must be able to work in a clean room environment with Personal Protective Equipment

..(confined area)

- Acceptance of incoming livers into the facility for processing

***Must be able to work a flexible on-call schedule including weekends and holidays***

Qualifications:

- Associate’s Degree in science or a related field.

- 0-3 years experience in a FDA and/or EU GMP regulated environment

- Familiarity of FDA and/or EU manufacturing/regulatory quality systems regulations

- Experience working in a clean room environment or biological containment facility

- Experience working with tissue/primary cells is preferred, but not required

- Knowledge of aseptic technique

- Ability to read and follow Standard Operating Procedures

- Must possess strong motivational skills and be able to work in a team environment.

- Must be detailed oriented and have excellent organizational skills

- Must possess effective written and oral communication skills

- Must be able to work in multi-faceted operation

- Experience with Microsoft Word, Excel and Outlook.

Point of Contact: Sonya Meheux, sonya.meheux@cytonetllc.com