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Manufacturing Technician III job in Rockville at Meso Scale Diagnostics, LLC

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Manufacturing Technician III at Meso Scale Diagnostics, LLC

Manufacturing Technician III

Meso Scale Diagnostics, LLC Rockville, MD Full-Time

POSITION SUMMARY:

Responsible for the execution of production schedules in consumables, kit or reagent manufacturing to meet production timelines in a fast-paced, high throughput industrial setting. This may include the production of coated plates, chemical buffers, biological diluents/reagents and/or assembled kits for customer order fulfillment. This position will manage processes, procedures and workflows within their designated department/area. This position may supervise the work of others.

DUTIES AND RESPONSIBILITIES:

  • Manage, track and communicate the planning of production, data analysis and status presentation
    o Compose production and equipment summary reports
    o Procurement of reagents (internal/external) and equipment
    o Critically reviewing data and assembly of batch records
    o Present data and results to colleagues and managers
    • Provides day to day guidance to team members:
      • Coordinate daily routine work for manufacturing technicians and ensure that duties are clearly defined and understood
      • Serve as point of contact for manufacturing team within the lab
      • Lead the training of manufacturing technicians to ensure they are fully proficient in the manufacturing processes


  • Program, operate and troubleshoot automated equipment used to perform and produce biological assays and/or reagents
  • Initiate and evaluate process improvements for manufacturing
  • Complete and revise appropriate documentation to support process and production procedures including data capture, forms, logbooks and inventory batch records
  • Develop, revise and implement SOPs
  • Participation in general maintenance including maintaining  cleanliness, supplies and equipment
    o Maintain physical inventory by processing/aliquotting/vialing/labeling materials
    o Prepare, update and report raw material, reagent and/or coated plate inventories
     Participate in year-end physical inventory
  • Follow laboratory safety precautions and use personal protective equipment properly
  • Cross Functional Collaboration
    o Represent Manufacturing in interdepartmental meetings
    o Work across departments to troubleshoot production problems
    o Lead manufacturing efforts in the transfer of processes and/or technologies to the Operations Group
  • May manufacture custom and/or prototype requests for customers
  • May occasionally handle BSL2 reagents
  • Specific duties may vary depending upon departmental requirements

    EXPERIENCE AND QUALIFICATIONS:

  • A high school diploma and at least five years of relevant manufacturing experience  required.
    • A degree in Biology, Chemistry, Biotechnology, Engineering or related field preferred

  • Experience with cGMP and/or ISO certification highly preferred

  •  A minimum of one year of experience as a team lead

    KNOWLEDGE, SKILLS AND ABILITIES:
    • Ability to lead, train, guide others to understand and comprehend subjects/duties
    • Ability to hold team accountable for deadlines and quality compliance

    • Ability to learn software applications/tools, as required
      o Proficiency in MS Office suite required
      o Proficiency with MRP/ERP and JDE systems preferred
    • Desirable skill sets may include but not be limited to the following:

    o Manufacturing immunoassays and/or reagents
    o Reagent stability testing
    o In-vitro diagnostic instrumentation and devices

  • Strong scientific fundamentals and analytical background
    o Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion
  • Ensure compliance for learning and adhering to standard laboratory techniques and safety precautions as presented (protein determination/pipetting/balance operation)
  • Demonstrated ability to work with automated vialing or bottling equipment
  • Independently execute mechanical equipment troubleshooting
  • Excellent oral, written communication and interpersonal skills
    o Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data
    o Effectively communicate performance goals and expectations

    PHYSICAL DEMANDS:

  • This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and frequent lifting up to 50 lbs
  • Up to 50% of the day may be spent at a lab bench and/or in the cleanroom

    WORK ENVIRONMENT:

    Standard industrial  manufacturing, logistics and/or cleanroom environment

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    Job ID: MANUF001986

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