Process Development Technician

Job Post Index 209EFA-Sy##
Location Andover, MA
Description: Description
  • Set-up and execute cGMP unit operations with a focus on Purification (Chromotography, flow through filtration, tangential flow filtration) and solution formulation. Includes cleaning and sanitization of the facility and equipment (CIP, SIP, COP, autoclaving, depyrogenation, etc).
  • Accurately follow oral, written and electronic instructions in the production area and document daily operations in GMP batch records and logs.
  • Operate manual and automated equipment. Individuals will be expected to learn and work with enterprise system such as LabWare LIMS and SAP.
  • Support implementation of new technology for process execution and/or analysis.
  • May be responsible for authoring and revising cGMP documents including batch records and SOPs.
  • Responsible for data entry and real time process monitoring.
  • Assist in inventory tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
  • Execution of Purification, Buffer preparation and glass wash activities in a multi-product, multi-line cGMP facility capable of manufacturing commercial, clinical and development drug substance.
Skills: Qualifications
  • Years of Experience 2-5.
  • Experience with chromatography columns, UF and VRF systems, flow through filtration, tangential flow filtration, and final fills are preferred.
  • Purification experience
  • Successful candidates will be flexible and adaptable, willing to work in a fast paced, dynamic environment.
  • HS Diploma + 3 years of experience
  • Associate Degree + 1 year of experience

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