Waltham, MA

  • Manufacturing Associate II- Biomanufacturing 2nd Shift

    Job Locations US-MA-Waltham
    ID
    2020-1184
    Category
    Manufacturing & Operations
    Type
    Full-Time
  • Overview

    This position is for the 2nd shift in the Biomanufacture group, however; cross training into other departments may be required.

    The successful candidate will play a key role in ensuring that the department’s production and quality goals are met. Applicants must have strong technical knowledge and problem-solving skills. Must be able to follow oral and written instructions accurately, learn complex tasks quickly, and complete tasks in a timely manner. Experience working in a GMP/document-controlled environment would be beneficial. Attention to detail, and the ability to work in a team environment are essential. Candidates must be willing and able to learn new manufacturing processes as the company grows and also to work overtime.

    Responsibilities

    • Contributes to the daily operation of the Repligen Affinity team, which will include the following:
      • Fermentation using a 3000L bioreactor
      • Product recovery using Microfiltration and Ultrafiltration
      • Aseptic strain handling and liquid fill/finish within a Bio-safety cabinet
      • Large scale column chromatography
      • Product recovery using tangential flow filtration
      • Large scale buffer/media preparation
      • pH precipitation
      • Sterile filtration
      • Aseptic liquid fill/finish
      • Equipment cleaning (CIP/SIP)
      • Chromatography column packing
      • Timely and accurate completion/review of production documentation
      • Entry of in-process data into trending databases
      • May be required to cross train into fermentation and/or chromatography column packing departments.
    • Maintain a safe working environment and follow all site safety procedures.
    • Ensures all manufacturing processes are carried out according to approved batch records and SOPs
    • Reviews batch records for accuracy and in a timely manner. Reports deviations to Quality Assurance. Participate in development and implementation of Corrective Actions

    Qualifications

    • BS degree in biological sciences, or a related field preferred, or a minimum of two years experience in biotech manufacturing.
    • Excellent organizational and communications skills
    • Proficient in using ERP systems, Microsoft Excel, Word, Power Point, Outlook                               
    • Must be resourceful and self-motivated
    • Must be willing to work overtime (including evenings and weekends) as required.
    • Must be able to lift 25 lbs unassisted.
    • Experience in LEAN manufacturing and 6 sigma a plus

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