Manufacturing Associate II - Downstream

Title: Manufacturing Associate I/II - Downstream Location:

Rockville, MD Type: 12 Month Contract potential for extension or hire Start Date: Immediate Overview: The Manufacturing Associate I/II participates in the cell culture manufacturing of biopharmaceutical drug substance to support multiple clinical programs.

This position will work in the manufacturing suite under GMP (Good Manufacturing Practices) to ensure that materials manufactured meet required specifications and regulatory requirements. Responsibilities Operate expansion and production reactors, conduct harvest operations, and order and account for consumption of raw materials and components. Operate bioprocess equipment under strict adherence to cGMP, OSHA and required policies and regulations.

Assist in the preparation and maintenance of reports and other documentation as applicable to the scope of operations in the manufacturing facility. Work in collaboration with the Quality Assurance group to fulfill quality management goals and ensure the highest quality manufacturing processes. Plan for raw material requirements by maintaining appropriate inventory of chemicals/consumables and ordering them as needed.

Coordinate sample testing and room release with QC. Assist with technical issues and problems. Assist with scale-up and basic trouble-shooting of technical issues and other problems encountered within the manufacturing process.

Monitor, maintain and calibrate laboratory equipment as needed. Monitor and audit work processes to ensure compliance and completion of targets. Prepare and revise batch records and SOPs, as well as drafting of technical reports.

Write deviation/incident reports as needed. Identify areas for improvement in manufacturing efficiencies and compliance. Assist with technology transfer from Process Development to manufacturing environment.

Prepare (wipe down) equipment for use in cleanroom environment. Maintain working inventories of supplies within the production area. Perform media preparation, buffer preparation, cell culture, and filtration processing steps.

Organize projects and data using Excel, Word, PowerPoint and a document control system. Maintain a clean and safe plant environment. Qualifications Education & Experience High School Diploma or equivalent and a minimum of five years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment; or Associate’s degree in a related discipline and a minimum of one year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment Prior experience following GMP rules and procedures M3