Job Title : GMP Manufacturing Associate / Manufacturing Associate

Location : Rockville, MD 20852

Duration : 11 months

Job Description :

• Basic understanding and knowledge of the following areas and ability to perform the activity with some supervisory guidance:
• Preparation, cleaning, sterilization, batching, pasteurization or filtration and delivery of media and solutions for cell culture and purification operations.
• Perform the set-up, operation, cleaning and break-down of process equipment.
• Perform sampling procedures on various analytical instruments to analyze cell culture, solution and/or product concentration characteristics.
• Operate Filter integrity devices to confirm the integrity of filters pre and post use.
• Perform process operations, equipment and instrument monitoring and trending to enable proactive identification of issues to escalate and correct with applicable departments.
• Set-up of fixed and mobile processing equipment and parts with CIP skids to carry out validated cleaning and sterilization processes.
• Follow appropriate standard operating procedures (SOPs), protocols and batch records/logbooks to safely perform process operations and document compliantly with good documentation and data integrity practices.

General knowledge of Microsoft Office Applications (Excel, Word, and Outlook).