The Manufacturing Associate I/II 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

Manufacturing Associate I 

• 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

OR

• Associate’s degree with one year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment

OR

• Bachelor’s degree in a related discipline with no experience

 Manufacturing Associate II 

• High School Diploma or equivalent and a minimum of three years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment

OR

• Associate’s degree in a related discipline and a minimum of two years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment

OR

• Bachelor’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

Knowledge, Skills and Abilities

•  Knowledge of cell culture techniques
•  Ability to write and revise technical documents
•  Ability to lift up to 30 lbs.
•  Ability to work occasional weekends or overtime as needed
•  Ability to follow detailed instructions and to maintain accurate records and notes
•  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 practices

Supervisory Responsibilities

None

Preferred Qualifications

• Previous GMP experience
• Ability to use MS Office (Word, Excel)

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email [email protected] or call (301) 354-3566 and/or 711 for TTD/TTY service.