• Manufacturing Support Technician III/Sr. Manufacturing Support Technician

    Category Manufacturing
    ID
    2018-1235
    Job Location
    US-MD-Rockville
    Type
    Regular Full-Time
  • 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 III/Senior Manufacturing Support Technician participates in the preparation of solutions used to manufacture biopharmaceutical drug substance to support MacroGenics multiple clinical programs. This position will work in the manufacturing suite under cGMP (Current Good Manufacturing Practices) to ensure that materials manufactured meet required specifications and regulatory requirements.

     

    Responsibilities and Job Duties

    • Perform 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.
    • Operate bioprocess equipment, balances, downflow booths, mixers, and pumps under strict adherence to cGMP, OSHA and required policies and regulations.
    • Maintain appropriate inventory of chemicals and consumables by ensuring the timely and accurate planning of raw material required and order as needed.
    • Prepare (wipe down) materials and equipment for use in cleanroom environment in accordance with procedures.
    • Draft and revise Solution Records, Work Instructions, Standard Operating Procedures and other GMP documents and reports related to the support work with minimal supervision. Write deviation/incident reports as needed.
    • 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.
    • 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. Coordinate sample testing and room release with the Quality Control group.
    • Monitor, maintain and calibrate laboratory equipment as needed. Assist with technical issues and problems and identify solutions and improvements.
    • Conduct basic trouble-shooting of technical issues and other problems encountered within the solution preparation process and equipment.  Make recommendation for short term and long term resolution.
    • Monitor and audit work processes to ensure compliance and completion of targets. Identify areas for improvement in manufacturing efficiencies and compliance and make recommendations to supervisor.
    • Assist with technology transfer from Process Development to manufacturing environment.
    • Organize projects and data using Excel, Word, PowerPoint and a document control system.
    • Maintain a clean and safe plant environment.
    • Mentor and train junior team members.

    Qualifications

    Education & Experience

    Manufacturing Support Technician III

    • High School Diploma or equivalent and a minimum of 5 years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment; or
    • Associate’s degree in a related discipline and a minimum of 3 years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment; or
    • Bachelor’s degree in a scientific field and a minimum of 2 years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment
    • Prior experience following GMP rules and procedures

    Senior Manufacturing Support Technician

    • High School Diploma or equivalent and a minimum of 7 years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment; or
    • Associate’s degree in a related discipline and a minimum of 5 years of related biopharmaceutical manufacturing experience in FDA regulated, controlled production environment; or
    • Bachelor’s degree in a scientific field and a minimum of 4 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 basic chemistry
    • Ability to mentor and train others
    • Engaged and committed team professional who is committed to generating quality products and professional work ethic driven by manufacturing time-lines
    • Strong organizational skills and attention to detail and ability to manage multiple projects
    • Ability to write and revise technical documents concisely and clearly
    • Technical accuracy and ability to perform mathematical calculations
    • Ability to safely operate production equipment in accordance with established practices
    • Critical thinker who can analyze data and respond quickly to manage manufacturing projects
    • Passion for continuous improvement
    • Independent thinker and self-learner
    • Manual dexterity
    • 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.

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