Upstream Manufacturing Lead

4 weeks ago

Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time
Position Overview

The Manufacturing Technician IV will work directly with a range of technologies. The Technician IV level provides an opportunity to stay on the technical track or work towards a supervisory path. Dependent upon assignment, the range of technologies may include any of the following:

Job Description

Upstream Unit:

  • Single-Use Cell Culture Vessels/Bioreactors up to 2000L
  • Bacterial Fermentation Culture Vessels up to 2000L
  • Alpha Wasserman Continuous Flow Centrifuges
  • Disposable Magnetic Mixing Bags and Totes
  • Cell Expansion and Propagation
  • Banking/Cryopreservation of Cell Lines and Viruses
  • Hyperstack, Cellstack, and other Adherent Cell Technologies
  • Plate counting, microscopic examination
  • Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation

Downstream Unit:

  • Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration
  • Medium to Large-scale Chromatographic systems (ÄKTA).
  • Pre-Packed Columns from 1L to 100L
  • Single use mixing systems (Pall & GE)
  • Single Use connectivity types such as GE DAC and Colder AseptiQuik
  • Bulk filling
  • Aseptic process simulation and drug product filling
  • Plate counting, microscopic examination
  • Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation

Buffer Preparation Unit:

  • Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs
  • Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs
  • Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures
  • Integrity testing of filters

Essential Functions Include:

  • Write and review standard operating procedures, buffer formulation records and batch production records.
  • Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs.
  • Maintain the confidentiality of proprietary company information.
  • Document and maintain activity records according to cGMP regulations and ensure junior team members are trained.
  • Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc.
  • Perform all other duties as assigned.

Technician IV Minimum Qualifications:

  • Bachelors degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field and 2 years of relevant experience; OR
  • Associates degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or related field and 4 years of relevant experience; OR
  • High School/GED with 6 years of relevant experience.

Join us FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential.

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