MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The Manufacturing Associate I/II 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 and Job Duties

• 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

Manufacturing Associate I

Education & Experience

• High School Diploma or equivalent with exposure to science and math coursework and a minimum of two years of related related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment

OR

• Associate 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

Education & Experience

Qualifications

Education & Experience

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

OR

• Associate 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.

Knowledge, Skills and Abilities

• 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.

Supervisory Responsibilities

None

Knowledge, Skills and Abilities

• Knowledge of protein purification techniques
• Ability to write and revise technical documents
• Ability to lift up to 20 kg
• 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 Microsoft 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 info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled