Manufacturing Associate I - Protein Purification

Role Summary

The Manufacturing Associate I participates in the manufacturing of biopharmaceutical drug product to support MacroGenics’ multiple clinical programs in the Protein Purification 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

• Participates in hands-on production in the manufacturing of commercial and clinical material in a GMP environment.
• Performs purification operations including filtration, chromatography, titrations, column packing, Tangetial Flow Filtration (TFF) and bulk fill.
• Consumes and scraps solutions, raw materials, consumables and components in SAP.
• Contributes to the creation and revision of Batch Records, Standard Operating Procedures, Material Specifications, and other GMP documents.
• Adheres to all SOPs and batch records under GMP regulations to document all manufacturing activities clearly and accurately.
• Maintains adequate supplies to perform routine equipment maintenance.
• Maintains manufacturing area in a clean, neat, and orderly condition at all times.
• Participates in a variety of projects designed to improve the quality, and efficiency of the manufacturing team.
• Follows all related safety policies and procedures when working with hazardous materials.

Qualifications

• 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.
• Associate degree with one year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment.
• Bachelor’s degree in a related discipline with no experience.

Skills

• Knowledge of protein purification techniques.
• Ability to write and revise technical documents.
• Ability to work occasional weekends or overtime as needed.
• Ability to follow detailed instructions and to maintain accurate records.
• Ability to work effectively in a team environment.
• Ability to successfully perform multiple tasks when required.
• Skills in problem-solving and troubleshooting.
• Ability to safely operate production equipment in accordance with established procedures.
• Ability to lift up to 30 lbs.