Description:
The Manufacturing Associate I participates in the manufacturing of biopharmaceutical drug product to support MacroGenics’ multiple clinical programs in the Cell Culture area. 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 And Job Duties
- Participate in hands-on production in the manufacturing of material for clinical trials in a GMP environment, including operating expansion and production reactors, conducting harvest operations, and ordering and accounting for consumption of raw materials and components.
- Contribute to the creation and revision of Batch Records, Work Instructions, Standard Operating Procedures, Material Specifications and other GMP documents
- Adhere to all SOPs and execute batch records under GMP regulations documenting all manufacturing activities clearly and accurately, including preparation records, testing records, equipment use records, and laboratory notebooks
- Maintain adequate supplies and perform routine equipment maintenance
- Maintain manufacturing area in a clean, neat, and orderly condition at all times
- Participate in a variety of projects designed to improve the quality, and efficiency of the manufacturing team
- Follow all related safety rules and procedures when working with hazardous materials
Qualifications
Education & Experience
- High School Diploma or equivalent with exposure to science and math coursework and a minimum of two years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment