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Manufacturing Associate III - Cell Culture

Manufacturing Associate III - Cell Culture

ID 
2017-1092
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 Associate III 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

  • Operate expansion and production reactors, conduct harvest operations, and order and accounting for consumption of raw materials and components.  Operate bioprocess equipment under strict adherence to cGMP, OSHA and required policies and regulations.
  • Prepare and maintain reports and other documentation as applicable to the scope of operations in the manufacturing facility.
  • Collaborate with the Quality Assurance group to fulfill quality management goals and ensure the highest quality manufacturing processes.
  • Plan for raw material requirements by maintaining appropriate inventory of chemicals/consumables and ordering them as needed.
  • Coordinate sample testing and room release with QC.
  • Assist with technical issues and problems and identify solutions and improvements.
  • Responsible for scale-up and basic trouble-shooting of technical issues and other problems encountered within the manufacturing process.
  • Monitor, maintain and calibrate laboratory equipment as needed.
  • Monitor and audit work processes to ensure compliance and completion of targets.
  • Prepare and revise batch records and SOPs, as well as drafting of technical reports.
  • Write deviation/incident reports as needed.
  • Identify areas for improvement in manufacturing efficiencies and compliance.
  • Assist with technology transfer from Process Development to manufacturing environment.
  • Prepare (wipe down) equipment for use in cleanroom environment. Maintain working inventories of supplies within the production area.
  • Perform media preparation, buffer preparation, cell culture, and filtration processing steps.
  • Organize projects and data using Excel, Word, Powerpoint and a document control system.
  • Maintain a clean and safe plant environment.
  • Participate in the training of junior team members.

Qualifications

Education & Experience

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

OR

  • Associate’s degree in a related discipline and a minimum of three 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
  • 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 time-lines
  • 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

 

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