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Manufacturing Support Technician II

Manufacturing Support Technician II

ID 
2018-1140
Category 
Manufacturing
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

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 Support Technician II performs tasks that support and enable the manufacturing of clinical lots for MacroGenics’ multiple clinical programs.  This position will work in the manufacturing suite under GMP (Good Manufacturing Practices) and produce materials necessary the next step of the manufacturing process ensuring compliance with all required specifications and regulatory requirements.

 

Responsibilities and Job Duties

  • Performs support tasks that enable the manufacturing of material for clinical trials in a GMP manufacturing environment, including weigh and dispense, buffer prep, media prep, facility cleaning, equipment cleaning, and raw material ordering in compliance with all SOPS and GMP regulations and with supervision. supervision on non-routine and more complex situations.
  • Participate in the creation and revision of Solution Records, Work Instructions, Standard Operating Procedures and other GMP documents related to the support work.
  • Execute solution records under GMP regulations and related SOPs.  Document all manufacturing activities clearly and accurately, including preparation records, testing records, and equipment use records.
  • Monitor and audit work processes to ensure compliance and completion of targets.
  • Work in collaboration with the Quality Assurance group to fulfill quality management goals and ensure the highest quality manufacturing processes. Coordinate sample testing with Quality Control.
  • Maintain chemical and supplies inventory and perform routine equipment maintenance and housekeeping ensuring that equipment and materials are available and adequate to set the manufacturing team up for success.
  • Participate in a variety of projects, as assigned, designed to improve the service, quality, and efficiency of the manufacturing support team.
  • Operate bioprocess equipment under strict adherence to cGMP, OSHA and required policies and regulations.
  • Follow all related safety rules and procedures when working with hazardous materials to maintain a clean and safe plant environment.
  • Organize projects and data using Excel, Word, Powerpoint and a document control system.

Qualifications

Education & Experience

  • High School Diploma or equivalent and a minimum of 18 months of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment 

OR

  • Associate’s degree in a related discipline and a minimum of 1 year of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment

OR

  • Bachelor’s degree in a scientific field and a minimum of 6 months of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
  • Prior experience following GMP rules and procedures

Knowledge, Skills and Abilities

  • Knowledge of basic chemistry
  • Ability to write and revise technical documents concisely and clearly
  • Technical accuracy and ability to perform mathematical calculations
  • Ability to follow detailed instructions and to maintain accurate records and notes
  • Strong organizational skills and attention to detail
  • Ability to work effectively in a team environment while demonstrating a commitment to generating quality products
  • Professional work ethic driven by manufacturing time-lines and passion for continuous improvement
  • Ability to think critically and analyze date and respond quickly to manage multiple manufacturing projects
  • Skills in problem solving and troubleshooting
  • Ability to safely operate production equipment in accordance with established practices
  • Ability to lift up to 30 lbs.
  • Ability to work occasional weekends or overtime as needed

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

 

For more information about our commitment to equal employment opportunity, please click here.