About The Position

Performs functions associated with cGMP manufacturing operations within a biologics production facility. The role includes working with engineers on setup and calibration tasks, and performing rework and quality testing related to production of parts, components, and final materials. Uses programs such as LIMS, SAP, and automated control systems to collect and evaluate operating data for on-line adjustments to products, instruments, or equipment. Determines and may assist in developing methods and procedures to control or modify the manufacturing process. The position is for the MD Fill (Aseptic Gown) B1 shift, 6:00 a.m.–6:30 p.m. Thursday, Friday, and Saturday, and every other Wednesday.

Requirements

  • High school diploma or equivalent experience and 2+ years of experience; alternatively, an associate degree in science and 1+ years of relevant experience; or a bachelor's degree and 0+ years of relevant experience.
  • Ability to acquire job skills and learn company policies and procedures to complete routine tasks.
  • Ability to perform routine assignments requiring limited judgment.
  • Ability to recognize deviations from accepted practices.
  • Ability to follow detailed instructions and work under close supervision.

Responsibilities

  • Ship finished materials.
  • Maintain inventory levels.
  • Sample in-process and raw materials.
  • Run glass washer and autoclave.
  • Prepare buffers and media.
  • Prepare equipment using CIP/SIP.
  • Perform cell culture, from vial thaw through production scale.
  • Perform column chromatography.
  • Perform tangential flow filtration.
  • Work with engineers on setup and calibration tasks.
  • Perform rework and quality testing related to production of parts, components, and final materials.
  • Use systems such as LIMS, SAP, and automated control systems to collect and evaluate operating data for on-line adjustments to products, instruments, or equipment.
  • Determine and may assist in developing methods and procedures to control or modify the manufacturing process.

Benefits

  • Paid time off, including vacation, holidays, and sick time.
  • Medical, dental, and vision insurance for eligible employees.
  • 401(k) for eligible employees.
  • Eligible to participate in short-term incentive programs.
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