Manufacturing Associate Ii/Iii - Protein Purification

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 350+ 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 III 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:

• Conducts purification operations including filtration, chromatography, titrations, column packing, and order and account for consumption of raw materials and components in SAP. Operate bioprocess equipment under strict adherence to cGMP, OSHA and required policies and regulations.

• Prepares and maintains reports and other documentation as applicable to the scope of operations in the manufacturing facility.

• Collaborates with the Quality Assurance group to fulfill quality management goals and ensure the highest quality manufacturing processes.

• Plans for raw material requirements by maintaining appropriate inventory of chemicals/consumables and ordering them as needed.

• Coordinates sample submission to Quality Control and Development groups.

• Assists with technical issues and problems and identifies solutions and improvements.

• Responsible for scale-up and basic troubleshooting of technical issues and other problems encountered within the manufacturing process.

• Monitors, maintains and assists with equipment prevention maintenance and calibrates laboratory equipment as needed.

• Monitors and audits work processes to ensure compliance and completion of targets.

• Prepares and revises batch records and SOPs, as well as drafting of technical reports.

• Writes deviation/incident /non-conformance reports as needed.

• Identifies areas for improvement in manufacturing efficiencies and compliance.

• Assists with technology transfer from Process Development to manufacturing environment.

• Prepares (wipe down) equipment for use in cleanroom environment. Maintains working inventories of supplies within the production area.

• Performs buffer preparation, chromatography, and filtration processing steps.

• Organizes projects and data using Excel, Word, Powerpoint and a document control system.

• Maintains a clean and safe plant environment.

• Participates in training of junior team members on column packing, chromatography, filtrations, nanofiltrations, UF/DF and fill.

Qualifications

Manufacturing Associate II:

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'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

Manufacturing Associate III:

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 four years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment

OR

• Bachelor's degree in a related discipline and a minimum of three years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment

• Prior experience following GMP rules and procedures

Knowledge, Skills and Abilities

• Knowledge of protein purification techniques

• Ability to write and revise technical documents

• Critical thinker who can analyze date and respond quickly to manage manufacturing projects

• Ability to mentor and train others

• Ability to manage multiple projects

• Strong organizational skills

• Engaged and committed team professional who is committed to generating quality products

• Professional work ethic driven by manufacturing timelines

• Passion for continuous improvement

• Independent thinker and self-learner

• Manual dexterity and attention to detail are required

• Technical accuracy and ability to perform mathematical calculations

• Strong interpersonal skills and the ability to work effectively and efficiently in a team environment

• Ability to work flexible hours, including possible overtime and weekends

• Ability to lift up to 30 lbs.

Supervisory Responsibilities

None

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

We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.